The Associate Manager, Corporate Quality Assurance - Auditing is responsible for executing GxP Quality Assurance (QA) auditing functions with an emphasis on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) quality systems that govern compliance programs for PTC commercial and clinical activities.
The incumbent supports and/or conducts internal and external GMP and GDP compliance audits of Contract Manufacturing Organizations (CMOs), vendors, laboratories, submission documents, etc.
The Associate Manager works cross-functionally with internal departments and external resources on GMP/GDP QA related issues and may assume additional responsibilities, as required.
The Associate Manager, Corporate Quality Assurance - Auditing supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Performs assigned internal and external audits to assure compliance with GMP and GDP regulations; evaluates the quality systems of Contract Manufacturing Organizations (CMOs), laboratories and other vendors and ensures that alignment is achieved regarding resolution strategies; champions corrective actions until fully implemented. This includes, but may not be limited to, the following activities:
Schedules, plans, and prepares CMOs, vendors, laboratories, submission documents etc. in accordance with audit plans.
Conducts audit(s) and prepares and submits audit reports for review and input.
Communicates audit results to stakeholders.
Assesses audit responses and collaborates with CMC colleagues and QA supervision to develop and ensure closure of CAPA plans.
Contributes to PTC’s understanding of worldwide regulations, guidelines and GxP practices and assists in helping to meet regulatory compliance and corporate business requirements. This includes, but may not be limited to, the following activities:
Maintains working knowledge of current FDA, EU and other global regulation and guidance governing Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) activities.
Applies global regulation, agency guidelines and internal procedures to assure compliance.
Supports Quality Management System (QMS) implementation and Operations efforts involving GMP audit activities. This includes, but may not be limited to, the following activities:
Contributes to GMP/GDP audit related metrics.
Assists in identifying and communicating CMC risks and opportunities for process improvement as determined through audit activities.
Contributes to Corrective and Preventive Actions activities resulting from audits.
Bachelor’s degree in a technical, scientific, or other relevant discipline and a minimum 5 years of relevant experience in Quality Assurance, Regulatory Affairs, Manufacturing or a related role in a regulated pharmaceutical, biotechnology or related environment working with various dosage forms including but not limited to Solid Oral, Injectable Drugs and Biologics, and Oral Suspensions.
Demonstrated ability to work as a team player: listens, promote exchanges, communicates, adapts and advises.
Demonstrated knowledge and understanding of GMP/GDP regulations and compliance regulatory requirements.
Experience conducting audits (GMP, GDP, electronic system audits), documenting and communicating audit results to relevant stakeholders and ensuring CAPAs are generated, thorough and brought to closure.
Demonstrated ability to perform QA reviews of audit-related documentation and other documents as necessary.
Demonstrated ability to work collaboratively with internal and external key stakeholders to facilitate continuous process improvement activities.
Proficiency with Microsoft Office.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with problem solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects.
15 – 35% travel post COVID-19
*Special knowledge or skills and/or licenses or certificates preferred.
Registered GxP Quality Assurance Certifications.
Experience with Ultra-Cold Chain (-80?F) product manufacturing and distribution is a plus
Internal Number: R1382
About PTC Therapeutics
PTC is a science-led, patient-centered biopharmaceutical company focused on discovering, developing and commercializing medicine for patients with rare disease.
BACK TO TOP
ASA Job Board is Just One of the Benefits.
Discover what else ASA has to offer!
The job you are trying to reach from was originally posted at ASA Job Board.