Compliance Auditor Quality Assurance

CHRISTINA PENNINGTON, CQA

aduf9y@r.postjobfree.com 858-***-****

SUMMARY

Results oriented quality assurance professional with experience in the pharmaceutical / medical device industry. Initiative-taking with strong organizational and written and verbal communications skills. Excellent collaborator capable of performing at an elevated level in a fast-paced dynamic environment. Experience in GMP manufacturing oversight of clinical and commercial drug substance and drug product. Proficient in FDA, ICH, and ISO 9001 quality management systems, quality compliance best practices, cGMP, cGLP, and cGCP. PROFESSIONAL SKILLS

• Quality Assurance and Compliance

• Contract Manufacturing Organization Quality Oversight

• Master Batch Record Generation, Review, and Disposition (Drug Substance and Drug Product)

• GMP Document Generation (SOPs, Protocols, Reports, Annual Product Quality Review, Specifications)

• Quality Assurance Project Management (Managed the Product Disposition Schedule for multiple products)

• Internal and External Auditing (Vendor audits, Partner audit, Health Authority/Regulatory Inspection Support)

• Change Control Management (Document Changes, CAPA, Deviation/Investigation Reports, Vendor Changes, Engineering Changes)

• Supplier/Vendor Qualification and Approval

• QA Subject Matter Expert on multi-disciplinary project teams for contract-client process qualification and process management. EXPERIENCE AND RESULTS

Turning Point Therapeutics, San Diego, California July 2021 to Present

(a wholly owned subsidiary of Bristol Myers Squibb Company) Manager, Quality Assurance

RESPONSIBILITIES: Vendor oversight over various CMC API and Drug Product activities. Review master and executed batch production records. QC Regulatory Submissions and external publications including manuscripts and posters. Review and approval of QC analytical methods, method validation protocols and reports, SOPs, and specifications. Review and approve Stability Protocols and Reports. Review change controls to ensure requirements are met and adhere to SOP requirements. QA support for manufacturing and laboratory deviations/investigations, Oversight of Vendor data review/ approval, protocol, and report review/ approval, and disposition of Turning Point drug substance and drug product. Perform tracking and trending of analytical data from the Quality Systems (CAPA/Deviation/Lab Investigations/OOS/Change Control) and assist in writing and reviewing periodic reports. Reviews manufacturing, environmental monitoring, and quality control data for in-process and finished products as part of the investigation process. Review and revise technical registration documents. Support Annual Product Review preparations and submissions. Conduct or assist with compliance audits as required. Perform a wide variety of activities to ensure compliance with applicable regulatory requirements. Work within a multi-disciplinary team to direct the various activities required for the management of multiple small molecule drug substance and drug product processes. ACCOMPLISHMENTS:

• Responsible for a variety of Quality Assurance functions primarily related to Repotrectinib and other development programs.

• Management of Contract Manufacturing Organizations (CMO): Master Batch Record review and approval. Executed Batch Record reviews and approvals; deviation resolution, and batch disposition including generation of certificates of analysis, release, and compliance. Responsible for adherence with the quality agreement provisions resulting in on time batch release supporting company timelines for lead drug candidate, Repotrectinib and three development compounds.

• Perform Quality Assurance review and/or document audits on Turning Point or contractor documents. Perform External Audits/Vendor Qualifications. Provide Partner Support ensuring all batches released within tight timeline to support NDA filings.

• Reviewed and revised technical registration documents to support NDA filing of Repotrectinib.

• Management of Vendor Qualification Program for all Turning Point Products. Prioritize vendors to support NDA filings. Creation of quality questionnaires, conduct qualification audits, creation of Quality Agreements, approval of vendors for use and maintenance of vendor relationship to ensure quality compliance. CHRISTINA PENNINGTON

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Halozyme Therapeutics, San Diego, California March 2017 to July 2021 Sr. QA Compliance Specialist II, Quality Assurance RESPONSIBILITIES: Primary responsibility is administration of the release process for two commercial biologic drug substances and one clinical drug substance. Additional responsibilities include Quality Assurance oversight of the Contract Manufacturing Organization that supplies the three biologic drug substance products. QA Liaison responsible for multiple partners (development and commercial) to provide support for all Quality Assurance and Compliance- related issues (batch disposition, change control management, investigations, deviation management, CAPA, continuous process monitoring and improvement, annual product quality reports, etc.). This includes all forms of communication with Partner QA counterparts. Managed the Quality oversight activities (development and commercial) for a Contract Manufacturing Organization. Work within a multi- disciplinary team to direct the various activities required for the management of multiple approved biologic drug substance processes. Able to collaborate and achieve Quality and Compliance objectives across multiple Quality systems (Partner, Halozyme, CMO). Provide a Point- of-Contact for Partner-related Quality Assurance issues (batch-related questions, change control management, etc.). Compilation of the Annual Product Review with respect to quality assurance activities. ACCOMPLISHMENTS:

• Responsible for a variety of Quality Assurance functions primarily related to Halozyme's rHuPH20 (Enhanze) programs.

• Management of Contract Manufacturing Organizations (CMO): Master Batch Record review and approval. Executed Batch Record reviews and approvals; deviation resolution, and batch disposition including generation of certificates of analysis, release, and compliance. Responsible for adherence with the quality agreement provisions. Ensure GMP compliance profile is maintained. Work with CMO/CROs to assess out of specification results, investigations, and deviations to closure in a compliant manner and ensure timely implementation of corrective actions. Ensure products meet regulatory requirements as well as any partner requirements.

• Provide Quality input for process and method monitoring and annual product quality reports Interface with QC, Manufacturing, Supply Operations, Product Development, Regulatory Affairs, and other disciplines in support of Halozyme's goals and initiatives for the product.

• Change Management: Perform assessments of raw material changes, process/manufacturing changes, and equipment/utility changes with relevance to regulatory filings and quality agreements.

• Perform Quality Assurance review and/or document audits on Halozyme or contractor documents. Perform External Audits/Vendor Qualifications. Provide Partner Support.

• Developed the batch review and disposition process to allow for efficient batch disposition (drug substance)

• Prepared audit presentations and support for Partner audits.

• Second chair multiple Partner audits/supported Regulatory/Health Authority inspections at CMO (no observations). Pacira Pharmaceuticals, San Diego, CA January 2011 to February 2017 Sr. QA Compliance Associate

RESPONSIBILITIES: Responsible for overseeing the activities related to the cGMP Quality Management involving quality systems regulatory compliance. Responsible for the identification, review and follow up on manufacturing related deviations, observations, findings, and corrective actions to ensure that all deviations are appropriately investigated, documented, and reviewed. Review and approve master batch records as a part of lot disposition according to established written procedures for all manufactured product in support of commercial manufacturing. Proactively implement process improvements with respect to cGMP Quality Management involving quality systems. Provide support for QA activities for regulatory compliance, (i.e., Management Review support, regulatory audits) Quality technical reviewer for manufacturing Batch History Records (BHRs), deviations, Change Notice (CNs), Non-Conforming Material Reports (NCMRs), or Corrective and Preventative Actions. Review both internal and external audit observations and recommend appropriate systematic CAPA improvements. Performs manufacturing support activities, inspects, and approve rooms, lines, and equipment prior to use by manufacturing Participates in Risk Assessment activities between Manufacturing and Quality Assurance and provide regulatory compliance perspective. Evaluate deviations, change controls, validation documents/protocols and provide regulatory assessment. Represent Quality Assurance on Pre-approval project team as well as post approval FDA/MHRA audits for commercial product. Support QA activities for regulatory compliance as required. CHRISTINA PENNINGTON

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ACCOMPLISHMENTS:

• Managed the QA review and approval process for multiple successful drug substance and drug product campaigns.

• Established a uniform method of batch record review for over four hundred lots a year.

• Provided training to QA batch record review team for media validations, reviews, and disposition.

• Supported multiple Regulatory/Health Authority inspections on site. Arena Pharmaceuticals, San Diego, CA 2007 to 2011

Senior QA Compliance Auditor 2008 to 2011

RESPONSIBILITIES: Responsible for implementing the activities related to the establishment of the internal cGMP Quality Audit Program involving quality systems regulatory compliance. Proactively implement process improvements with respect to internal and external audit programs. Development of CAPA process for tracking and trending corrective actions for internal and external GMP audits. Auditing of internal GMP departments and external GMP vendors for acceptability; preparations of audit reports and maintenance of internal and external vendor audit files. Review both internal and external audit observations and recommend appropriate systematic CAPA improvements. Maintenance of internal and external audit files, internal audit schedule and support of vendor qualification and compliance. Participates in Risk Assessment activities between Development and Quality Assurance and provide regulatory compliance perspective. Evaluate change controls and provide regulatory assessment. Represent Quality Assurance on Pre-approval project team. Support QA activities for regulatory compliance as required.

ACCOMPLISHMENTS:

• Implemented Internal Audit program, Internal Audit Schedule and successfully completed eight department audits within first year.

• Creation of complete internal and external audit files QA Compliance Auditor IV 2007-2011

RESPONSIBILITIES: Responsible for preparing clinical site investigators for upcoming PAI in support of NOA for novel NCE. Support Clinical QA activities for regulatory compliance in preparation for PAI activities. Audit Phase Ill clinical investigators for compliance to established Good Clinical Practices (GCP) guidelines. Ensure clinical trial protocol compliance, clinical site activities, CRFs, informed consent review, appropriate delegation of authority, adequate training for all site staff, protection of rights, safety and welfare of study subjects and preparation of clinical investigators for possible PAI audit by FDA ACCOMPLISHMENTS:

• Administered 7 Clinical QA Audits for preparation of PAI audit by FDA.

• Collaborated with Clinical QA Site leads for observation resolution and closure. Biosite Inc., San Diego, CA 2006 to 2007

Quality Assurance Auditor, Quality Assurance

Responsibilities: Lead / Conduct internal audits. Conduct external audits of critical vendors. Review / approve vendor surveys. Implementation of process improvements with respect to the quality audit program. Development of metrics for measuring the effectiveness and overall quality of the audit program and process improvements. Provide support for QA activities for regulatory compliance, (i.e., Management Review support, regulatory audits) Analyze audit observations and recommend appropriate systemic CAPA improvements. Lead team in implementing systemic CAPA improvements. Responsible for analyzing and trending quality data with respect to the internal/external audit function. Maintenance of internal and external audit files, internal audit schedule and support of vendor qualification and compliance.

CHRISTINA PENNINGTON

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Dexcom Inc. 2006

Quality Assurance Specialist Ill / Sr. - Product Release RESPONSIBILITIES: Responsible for assignments related to activities involving quality systems, compliance, regulatory, manufacturing, and final product release. Review and approve lot history records as a part of lot disposition according to established written procedures for all manufactured product in support of commercial product release. Identification, review and follow up on manufacturing related deviations, observations, findings, and corrective actions to ensure that all deviations are appropriately investigated, documented, and reviewed. Provide on-site system implementation, training, and support resulting in an effective, cGMP Training program. Creation, assembly, and conduction of GMP training documents in support of continuous GMP training. Training presentations include cGMPs and GDPs. Review and enhancement of regulatory compliance related documents such as SOPs, Specifications, LHRs, DHRs and CAPAS. Coordination of in-house and external clinical trials in-regards to product disposition, review, and release. Favrille Inc., San Diego, CA 2004 to 2006

Quality Assurance Specialist Ill / - Lot Release

RESPONSIBILITIES: Responsible for review and disposition of batch records in support of phase Ill clinical trial. Review and approve master batch records as a part of lot disposition according to established written procedures for all manufactured product in support of phase Ill clinical trial as well as in support of commercial manufacturing. Generation, review, and/or enhancement of regulatory compliance related documents such as SOPs, Specifications, Investigations and Exception/Deviation Handling. Identification, review and follow up on manufacturing related deviations, observations, findings, and corrective actions to ensure that all deviations are appropriately investigated, documented, and reviewed. Monitors analyze and trend compliance related metrics. Provide on-site system implementation, training, and support resulting in an effective, cGMP Training program. Creation, assembly, and conduction of GMP training documents in support of corporate goal of GMP training. Training presentations include, cGMPs, GDPs, NHO and Exception Handling. Provide support during audits by regulatory agencies and consultants. SEQUENOM, San Diego, CA 2000 to 2004

Quality Assurance Associate – Quality Services 2003-2004 RESPONSIBILITIES: Responsible for assignments related to multiple projects with diverse scope of activities involving quality systems, compliance, regulatory, manufacturing and lot release. QC device history records, production batch records, analytical data, and deviations (COs, DNs and NCMRs) associated with a product for release. Auditing of both internal and external contract vendors for acceptability; preparation of audit reports and maintain surveillance audit documentation as well as maintaining internal/external vendor audit files in accordance with ISO 13485:2003 and 21 CFR 820. Development and review of applicable SOPs and work instructions. Implementation of a company -wide Quality System in compliance with ISO 9001:2000. Maintain and assess corporate compliance to the established Quality System to include both internal and external customers. Development and creation of specifications for an internal CAPA database as well as an internal training documentation database. Project Coordinator - Clinical Genetics I DNA Banking 2002-2003 RESPONSIBILITIES: Coordinate and manage Sample Collections for SEQUENOM. Responsible for all aspects of sample collections with regards to in-house Clinical Genetics program. Assured investigator compliance with GCP responsibilities, IRB, Protocol, Informed Consent, Safety Reporting, and documentation requirements. Development and Review of Clinical and Production data for accuracy, completeness, clarity, and compliance. Audit and monitor source data verification (SDV); comparison of CRF documents against source data to assess, identify and resolve data discrepancies. Development and implementation of internal documentation to support processes for Genetic Services, Clinical and Production Provided all handling of internal and external aspects (monitoring and administrative) of clinical collections. Worked closely with Project Manager(s) to establish project specific quality standards, needs and data analysis requirements. Documented, tracked, and administered financial aspects of sample collections with Finance and Business Development. Determined project feasibility, timelines and identified project milestones and personnel accountabilities. Research Associate Ill - Genomics I Pharmaceuticals 2000-2002 RESPONSIBILITIES: Management of Genomics Department projects for SNP Validation within the Genomics Laboratory (Over 250,000 MassARRAY assays established and validated) Responsible for implementing research and technical procedures acting as a liaison among the Genomics group between Genetics Services, HTC Operations and Technology. Creation and maintenance of data analysis records to support the creation of a High-Throughput Facility and reviewed work outputs for accuracy, completeness, compliance, and clarity. Simultaneously track/manage multiple projects through Genomics HTC about quality of work, implementation of rework, finish data and project statistics. Interviewed, trained, and supervised new research associates on the tools created to complete work within the Genetics Services Group.

CHRISTINA PENNINGTON

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ACCOMPLISHMENTS:

• Implementation of Automated Analytical Data Analysis and Quality Control/Quality Assurance Measures for the Genomics Lab/High-Throughput Facility; identifying parameters for "Red Flags" that should halt the laboratory process during data analysis and interpreted trends among processed data and implement guidelines for data quality on a project-specific basis. EDUCATION

Bachelor of Science, BIOLOGY

Mount St. Mary’s University – Los Angeles, California Graduate Non-Matriculate Student

University of Washington – Seattle WA

Professional Certificate of Proficiency, Biotechnology Lab Specialist, Shoreline Community College, Shoreline, WA PROFESSIONAL TRAINING

Human Subjects Protection and IRBs, UCSD Extension Program Mechanisms of Disease and Medical Terminology, UCSD Extension Program Action Management, SDSU Professional Development Program Front Line Management, SDSU Professional Development Program Managing a Diverse Workforce, SDSU Professional Development Program

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