Quality Assurance Control

DOUGLAS F. FORMAN

Johnstown, CO

848-***-**** ****.*.******@*****.***

EXECUTIVE SUMMARY

CORE COMPETENCIES

Strategic Planning & Organizational Leadership

Third Party/External/Internal QA Auditing

Change Management & Process Reengineering

Staff Management & Workforce Planning

Operational Streamlining

Quality Control & Regulatory Compliance

Team Leadership, Motivation & Mentoring

Client & Vendor Relations

Budget Planning & Forecasting

Technical Writing

Special Project Management

Vendor Management

CMO Due Diligence and Management

Quality Agreements

RECENT EMPLOYMENT EXPERIENCE

AGC Biosciences, Boulder, CO March 2021 – January 2024

Senior Quality Manager Operations

9 Direct Reports

Reported to the Site Quality Director responsible for creation of the QA Operation Group which is responsible for batch record and logbook review, floor triage of events/deviations, CAPAs and Change Controls that were related to manufacturing, supply chain and engineering groups

Responsible for the creation, organization and recruitment of Quality Assurance Operations Group

Created new-hire training program for QA Associates and Inspectors

Designed batch record and logbook trackers

Created QA operations metrics tracking turn-around times for the review of batch records as well as errors found within batch records and logbooks

Developed batch record and logbook review training

Instructed QA operations members on triage for events/deviations

Chaired “5S’ programs related to Quality

Participates in client audits, as well as internal audits

Serve as QA member of Client Support, Deviations and Change Control Boards

Created SOP's and training guides for projects involving multi-departmental coordination

Established key process indicators (KPI’s) and implemented preventive and corrective actions to eliminate the root causes of poor quality and delivery problems

As a member of the management team, set annual goals and continuous improvement initiative

Served as point of contact for all customers (established and potential) regarding quality objectives, procedures and concerns.

Oxford Pharmaceuticals, Birmingham, AL (Site shut due to COVID) September 2020 –March 2021

Site Quality Assurance Head

9 Direct Reports

Reports to the President and challenged with building and maintain Quality Systems, QA Operation, Internal/External Auditing, Vendor Management CMO management and Batch Release

When quality-related issues arise, provide leadership, and proactively lead the team of colleagues responsible for the process of triaging, scoping, performing preliminary investigation, and documenting incidents.

Responsible for ensuring a robust initial assessment and appropriate identification and containment of impacted product when investigating product quality concerns.

Responsible for Quality Systems and operations

Oversee CMO partners

Perform initial QA review of incidents at the and determine the level of investigation required.

Involved in determining root cause, consulting on corrective and preventive actions, and ensuring actions are implemented properly.

Perform QA review and approval of Investigation reports (manufacturing and consumer complaints); provide QA review and approval of Investigation CAPAs and commitments. actions are implemented properly.

Write, review, and revise Standard Operating Procedures (SOPs) as necessary.

Build a culture of continuous improvement to improve quality behavior and sustain results.

Ensure manufacturing and packaging activities are operating under a state of GMP compliance.

Ensure processes are in place to accurately and efficiently perform batch documentation review.

Act as the Quality Authority and provide QA review and final approval of protocols, master batch records, site SOPs, and other documentation.

Review and provide assessments for change controls.

Plan the effective use of labor and materials, and lead teams on special projects associated with the assigned area of responsibility.

Responsible for assigning the correct training activities for quality team members and ensuring that individuals are up to date with meeting their training requirements.

Create team-building activities and motivate individuals on assigned team.

Oversee implementation of CAPA’s assigned to Quality Assurance.

Responsible for the development of metrics, dashboards, whiteboards score cards, and tracking and trending for critical systems for Quality Assurance. •

Participates in plant cross-functional projects.

QA member of Process Validation team.

Reviewed Equipment Qualifations in manufacturing and the laboratory. ease, including investigations, document control, change control, inspections (internal and vendor).

FOLIUM BIOSCIENCES, Colorado Springs, CO September 2019 – September 2020

Quality Assurance Manager (Site shut due to COVID)

Establish, implement and maintain quality systems and compliance programs that support adherence to 21 CFR Parts 111 and 117.

Prepared Quality Manual and Quality Policy

Managed CMO groups

Assist with writing SOPs and makes recommendations to stakeholder SOPs with respect to continuous quality improvement.

Chaired the material review board and quality review board.

Provided responses to customer and regulatory requests, audits and quality updates.

Oversaw Vendor Management and

Provided QA oversight to contract manufacturers and analytical testing laboratories.

Generated management review reports and metrics.

Supported the development, deployment and execution of cGMP training for all Folium manufacturing sites.

Supported internal and external audit plans by executing self-inspections, creating audit surveys and performing site audits based on risk analysis.

Owner of QA compliance process includes coordination of day-to-day operational activity (packaging, manufacturing, laboratory), document control, participation in product enhancement and quality training of all staff.

Dr. REDDY’S LABORATORIES Inc., Princeton, NJ August 2012 – June 2019

Senior Director of Quality Assurance and Logistics Quality NAG

9 Direct Reports

Reports to the Senior Vice President of Quality and Scientific Affairs. Challenged with heading the corporate quality function with additional oversite of two solid dose manufacturing plants and an API facility, including third party manufacturing and packaging operations, quality systems, CMO’s and 3PL operations.

Responsible for coordinating, organizing and leading all Quality Assurance activities for US plants (3) and the US Corporate office.

North American Manager of Quality Systems

Managed CMO partners

Responsible for the Vendor Management program

Prepared, coordinated and led regulatory and DEA inspections.

Global Manager of Product Complaints

North American Manager of FAR and Recalls; including all products made in India.

NAG Team leader for laboratory and manufacturing investigations

Management and oversight of CMOs (Manufacturing, Packaging organizations, Contract Laboratories

Reviewed and approved OOS/OOT investigations

Managed controlled substance and List 1 product activities.

Presented a written proposal and justified the return on investment to purchase software solutions for global complaint management and electronic batch record review that has resulted in not having to increase the QA staff in two years.

Part of process validation

and computer validation teams.

Initiated learning software management systems that is now utilized globally

Maintained the system for Quality Agreements for all vendors and third party contracted organizations.

Provided leadership as interim QA R&D director ensuring timelines and continuity.

Quality Representative of US product launch team

US led on Quality Systems harmonization project

Interface with US FDA for all site (US and India) audits, audit responses, recalls and FARs.

Organized and scheduled Management Review Meetings (Review of Quality Systems) for all US plants.

North American Manager of FAR and Recalls; including all products made in India.

Managed the creation and operation of a cGMP QC lab at DRL’s Middleburg, NY API site

Responsible for the oversight of the NAG, Princeton Quality team that is responsible for batch

release, stability, reserve sample program, training, OTC vendor set-up and maintenance,

CMO/CPO audits and quality systems

Interacted daily with all levels of internal management as well as cross-functional teams and business units.

Provided QA oversight and technical support to contract packagers, assure products conform to requirements and identify risks/issues with our CPOs.

Met with vendors, customers and company personnel to discuss and resolve quality problems as required.

Executed Quality compliance activities: SOP approval, deviations, CAPAs, change management and continuous quality improvement projects.

Established and executed regional cGMP training programs.

KVK TECH, Newton, PA November 2011 – August 2012

Quality/Compliance Manager (Temp position)

5 Direct Reports

Reported to the CEO charged with modernizing the quality systems, developing the quality staff and project lead for site expansion and new site development. Planned, promoted and organized training activities related to quality. Evaluated and updated instrument/equipment qualifications in accordance with industry standards and cGMP.

Responsible for Quality Agreements, batch record review and release of CMO finished products.

Chair the SOP evaluation/revision committee that has been responsible for the creation and revision of over 130 SOPs since Jan 2012.

Led general cGMP inspection no 483s, Led DEA inspection no observations.

Oversight of the Vendor Management program

Reviewed and approve OOS/OOT investigations

Responsible for the vendor audit program and approved vendor’s list

Led QA external auditor (APIs, excipients, CMO, CPO)

Harmonized the deviation and investigation practices.

Created a training committee that is responsible for authoring departmental training manuals and hands-on-training modules.

Developed a Quality Systems database that allows executive management to keep current on open investigation, CAPAs, change controls, training gaps and planned deviations.

Created a Quality System corrective action plan that identified and corrected cGMP deficiencies in manufacturing, laboratory, process, packaging, documentation, vendor qualification and equipment qualification.

Performed internal and external audits of API and excipient manufacturers, contract manufacturing and packaging organizations.

Reviews and approved process and computer validation reports, as well as equipment/ instrument qualifications and calibrations.

Created, organized, staffed and implemented the QA Document Control Group and centralized the document control management system.

Created and administered the first quality and compliance program within R&D

Improved the Quality Groups efficiency by cross training QA Inspectors with respect to sampling raw materials, packaging room/line clearance and in-process testing and manufacturing room/equipment

clearance and in-process testing.

Reported the progress of the quality and facility improvement plans as well as the progress of weekly GMP training, equipment/instrument qualification review and SOP evaluation.

PAR PHARMACEUTICALS, Spring Valley, NY March 2011 – November 2011

Senior Auditor – Compliance (Temp position)

Reporting to the Senior Vice President of Quality and Compliance. Charged with establishing, implementing and maintaining quality assurance and compliance programs associated with the company SOPs, policies and cGMPs

Planned and performed compliance audits of internal operations as they relate to SOPs and cGMPs.

Planned and performed external compliance audits of suppliers, contract manufacturers, contract laboratories and contract packagers including due diligence audits.

Responsible for the management of the approved vendor’s list

Led 3 PAI inspections no observations, 2 general cGMP inspections 2 observation in total considered minor; Led 2 DEA inspections no observations.

Reviewed procedures, regulatory filings, and reports for compliance with regulations and internal standards

Developed and maintained functional area SOPs, plans and report templates.

Maintained the compliance database of observations for quality analysis and assessment and identifies compliance risks (Track Wise)

Ensured training of QC and manufacturing staff via participation in the developmental training activities and/or conduct of training on procedures.

Attended and participated in internal and external projects, product, and development meetings as needed.

Coordinated activities associated with regulatory agency inspections and participates in the preparation of responses to regulatory agencies.

SUN PHARMACEUTICALS, Cranbury, NJ December 2008 – March 2011

Manager –Quality Assurance

14 Direct Reports

High profile Manager charged with leading quality assurance and compliance groups assembled to control commercial operations in conjunction with handling the forming and sustaining of Quality Systems. Execute technical review of CMC section of ANDA filings to verify submission quality to FDA and cut number of deficiency letters received. Furnish final approval of production records, material specifications, development, validation protocols and reports, QC test methods, SOPs, and forms.

Streamlined deviation process to guarantee timely review and approval of laboratory and non-laboratory investigations that yielded a decrease in the backlog of overdue deviations.

Managed the review of CMO batch records, investigations and release of finished product.

External and Internal QA Audit lead charged with performing cGMP audits on API and excipient manufactures, CMOs, CPOs, as well as developing a local audit team and auditor training program

Explored root cause and corrective/preventative actions (CAPA) for deviation investigations while recognizing disposition of non-conforming materials.

Led DEA Diversion investigation 7 observations were made ranging from Major to Minor

Conceptualized and introduced Batch Error Tracking System to obtain, examine, and rectify persistent errors and events noticed during batch review.

QA representative on process validation committee.

Reviewed and approved instrument and equipment qualifications and calibrations

Steered discussions on assimilating three separate document control areas (QA, QC, and R&D) into single QA controlled function; this eradicated redundant and conflicting documentation practices.

Propelled directives that amplified cycle time to process quality records and diminished variations.

Developed, plans and implements Quality Assurance processes, programs and strategies based on current regulatory, compendia and corporate quality systems.

Ensured Quality Systems are compliant with corporate and written procedures such as Annual Product Reviews, Complaints, Investigations and CAPA.

Reviewed, tracked and trended all quality events such as incidents, corrective actions, laboratory variations, OOT and OOS investigations, and change control.

Developed a quality documents group that is responsible for the creation of CVMP, PVMP, cleaning protocol/reports, process validation protocols/reports and APRs

Developed a “Qualified Trainer” program across all US facilities (4), as well as harmonized cGMPs, CAPA, and investigation training programs.

Centralized the external auditing programs of all US facilities (4) reducing the cost of the program and increasing the efficiency of the audits by reducing redundancies

PAR PHARMACEUTICALS, Somerset, NJ/Spring Valley NY September 2004-December 2008

Senior Manager Quality Systems/Operations

5 Direct reports

Senior Manager recruited to direct the quality assurance and compliance groups at two facilities, R&D and commercial operations, while assisting with arranging CMC information for regulatory submissions to be include in NDAs, and ANDAs. Evaluated and approved all controlled documents including SOP's, master and executed batch records, validation protocols/final reports, method transfers, and method validation.

Responsible for the oversight of all quality systems (commercial and R&D) at Par Pharmaceuticals in Somerset, New Jersey and Spring Valley, NY.

Reported to executive management regarding quality performance, and the progress of

meeting defined goals and include this information in the monthly Corporate QA

report to QA Executive Management.

Oversight of CMO’S and Contract Testing Labs

Led 2 PAI inspections no observations, Led 2 DEA inspections no observations.

Severed as “Man in the plant” for CMO, as well as reviewed manufacturing/packaging records and deviation closures for the CMO facility.

Led the internal audit program to verify compliance with cGMPs and determine the effectiveness of the company’s quality systems and procedures.

Conducted audits at third party manufacturing, testing, packaging and warehouse / distribution operations to assure adherence to FDA requirements. Issue audit reports and follow-up on corrective actions.

Performed cGMP QA audits on all new API and excipient manufactures as selected by Research and Development.

Participated in Product Development teams to ensure ICH and regulatory requirements are incorporated as part of the developmental process.

Provided direction and coordinated daily departmental activities including hands on support in daily commercial and R&D activities as needed.

Responsible for issuing and concluding all investigations. (Root Cause and CAPA)

Assisted in preparing CMC information for Regulatory Submissions including NDAs, and ANDAs.

Reviewed and approved all controlled documents including but not limited to: SOP's, Master and Executed Batch Records, Validation Protocols/Final Reports, Product Development Reports, Stability Protocols, Method Transfers, and Method Validation.

Managed and directed the change control committee.

Created and delivered training modules on cGMP topics, as well as in response to findings from internal audits.

QA representative of Empower Validation, J.D. Edwards’s implementation and LIMS evaluation and implementation teams.

Created and directed the review groups for production data, laboratory data, and batch release between sites as well as contracted facilities for commercial and R&D activities.

Streamlined data flow from the Laboratories to the Product Development increasing efficiency and ensuring targeted submission and Bio dates.

Merged component testing between sites, reducing overall testing between the facilities by approximately 30%.

Experienced with solid dosage (ODT, IR, CR, Gel caps) and semi solid dosage forms.

CLAY-PARK LABS (PERRIGO), Bronx, NY April 2002-September 2004

QA/QC Compliance Supervisor

8 Direct Reports

As Compliance Supervisor, accountable for superintending quality assurance and compliance group that conducted review of batch records, laboratory testing, method validation, process validation, instrument/equipment qualification, and internal/external auditing. Function as liaison between Technical Services group, QC and AR&D laboratories in effort to resolve issues with equipment or quality assurance.

Performed QA audits of QC and Analytical Research and Development (AR&D) activities to include raw materials, finished product, and stability testing in GMP environment as well as API and excipient manufacturers.

Completed data review/approval for batch records, analytical method validations, protocols, cleaning validations, and broad range of testing for ANDA submissions to FDA.

Teamed with AR&D to craft comprehensive monograph project that included review, revision, approval, and implementation of over four hundred raw material monographs.

Partnered with Technical Services division to evaluate and approve executed laboratory instrumentation maintenance/calibrations, IQ, OQ, PQ protocols and final reports.

CELSIS LABORATORY GROUP, Edison, NJ September 2000-April 2002

QC Data Reviewer/Auditor

Essential reviewer/auditor selected to control various activities that included work generated by laboratory, monitor and document laboratory, communicated with clients about services offered, quote tests conducted, resolved issues and convey results.

Assessed all documentation produced from lab, in-house/ vendor OQ’s and PQ’s, and reports involved with Millennium data acquisition software validation.

Key contributor to arrangement of method transfers and validation studies for chemistry.

Educated newly hired chemists to preserve proper laboratory records (21 CFR Part 211.194) and handle hazardous waste collections.

SAFETY KLEEN CORPORATION, Linden, NJ January 1998-September 2000

Lab Supervisor

8 Direct reports

As lab supervisor, responsible for sustaining laboratory compliance with EPA, laboratory function, review of laboratory data, execution of instrument qualifications (IQ, OQ, PQ), and hosting of EPA site inspections, training, and personnel reviews.

Launched directives to track, trend and educate in effort to decrease amount of laboratory errors by 20%.

EDUCATION AND PROFESSIONAL DEVELOPMENT

Bachelor of Science in Chemistry, Richard Stockton State College, Pomona, NJ

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