The Manager, Corporate Quality Assurance - Corporate Standards is responsible for managing the GxP Quality Assurance (QA) functions pertaining to Corporate Standards and Quality Technical Agreements (QTAs) 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 is responsible for the creation and continuous improvement of corporate standards and for the implementation of those standards across multiple PTC global sites. In addition, the incumbent supports the management of the QTA program and process for PTC manufacturing partners and suppliers.
This involves engaging and collaborating with cross functional internal teams and external vendors to evaluate CMC processes, procedures, and activities to ensure PTC corporate standards and practices are aligned with relevant industry standards and regulatory guidelines.
The incumbent works cross-functionally with internal departments and external resources on GMP/GDP QA related issues and may assume additional responsibilities, as required.
The Manager, Corporate Quality Assurance – Corporate Standards supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Responsible for the creation and maintenance of PTC GMP/GDP corporate standards to maintain GMP/GDP compliance with applicable regulations, guidelines and current regulatory requirements.
Performs management of the QTA program 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 within the QTA. This includes, but may not be limited to, the following activities:
Prepares QTA templates.
Prepares and manages QTA plans.
Assesses QTA comments and collaborates with QA supervision to develop and ensure completion of each QTA.
Assists with GMP/GDP inspection readiness activities for regulatory authority inspections pertaining to Corporate Standards and QTAs.
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 regulations, agency guidelines and internal procedures to assure compliance.
Supports Quality Management System (QMS) implementation and Operations efforts involving GMP/GDP Corporate Standard and QTA activities as PTC transitions from paper to electronic systems. This includes, but may not be limited to, the following activities:
Contributes to QA review of SOPs and documentation related to Corporate Standards and QTAs, as well as other related documents as required by regulation and as appropriate.
Contributes to GMP/GDP Corporate Standard and QTA metrics.
Assists in identifying and communicating CMC and QA risks and opportunities for process improvement as determined through QTA and Corporate Standard review activities.
Contributes to Corrective and Preventive Actions resulting from Corporate Standard and QTA review activities.
Describe the following criteria, which are necessary to effectively perform the position:
* Minimum level of education and years of relevant work experience:
Bachelor’s degree in a related discipline and a minimum 5 years of relevant experience in Quality Assurance, Regulatory Affairs, Manufacturing or a related role in a pharmaceutical, biotechnology or related environment.
* Special knowledge or skills needed and/or licenses or certificates required.
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.
Demonstrated ability to perform QA reviews of SOPs, QTA and Corporate Standard related documentation and other documents as necessary.
Experience writing and reviewing SOPs which support GMP/GDP QTA and Corporate Standard activities/functions.
Demonstrated ability to work collaboratively with internal and external key stakeholders to facilitate continuous process improvement activities.
Ability to contribute to the identification and generation of metrics that help drive GMP/GDP process improvements and increase compliance.
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.
*Special knowledge or skills and/or licenses or certificates preferred.
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.
Registered GxP Quality Assurance Certifications.
Experience supporting regulatory agency (e.g., FDA, EMA, MHRA) inspections.
* Travel requirements
Up to 10%
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.