- Responsible to ensure commercial and clinical (IMP) products fulfill the specified requirements and they are released in legal compliance with the customer markets as well Roche global internal PQS requirements.
- Lead implementation and surveillance of the state of control of manufacturing processes, analytical controls and support operations in accordance with the current requirements of Good Manufacturing Practices.
- Primary responsibility of escalation of significant quality issues through the appropriate escalation channels commensurate with the issue as defined in current governing documents
- Establish strategic goals and objectives and maintain full strategic responsibility for the Quality Assurance organization.
Leadership and People Management:
- Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term. Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
- Act as a leader within Quality Site Leadership team and primary deputy for the Quality Site Head.
- Accountable for overall budget and financial performance of the QA Operations function.
- Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
- Embody PT lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.
Technical and Functional:
- Provide Quality Assurance oversight throughout the end-to-end production operations including Chain of Custody and Chain of Identity, assuring current GMP compliance with strong frontline involvement
- Provide leadership for applicable QA decision making bodies and provide QA input for issues escalated
- Review and approve QA documentation to ensure GMP compliance to all relevant regulations. Ensure documentation supports a continuously compliant state at HIT and a continual state of readiness for their areas of responsibility for agency inspections.
- Management of Deviation Management & CAPA systems, ensuring robust, thorough and complete investigations (including root cause analysis, product quality impact, interim/mitigating/long term actions and documentation) the appropriate oversight and support the implementation of the actions through appropriate records, timely resolution, action and closure of the quality system records, and their effectiveness.
- Accountable for monitoring and continuous improvement for relevant Quality key performance indicators
- Responsible for complaint management execution, including oversight of complaint intake, timely evaluation, trending and issue escalation.
- Assure the efficient, timely, batch record review and GMP compliant product release.
- Responsible for lot disposition and release of Commercial and Clinical products according to the approved registration dossiers, ensuring internal standards are achieved and in compliance with local and international laws (e.g., Qualified Person/ Responsible Person)
- Manufacturing, all Site functions, PTD, Medical and Regulatory affairs, Affiliate Quality Assurance Management, Regulatory (PTR)
- Global Quality System and Quality Management, External Quality, Supplier Quality
- Bachelor Degree (Pharmacy, Pharmaceutical, bioengineering, Chemistry or other relevant area preferred. Depending on local law, in Europe: pharmacist)
- Graduate or higher-level Degree is preferred
- 10 or more years work experience in the pharmaceutical or related life science industry
- 6 or more years people leadership experience
- 4 or more years experience in the validation of pharmaceutical manufacturing facilities, equipment and computers
- Experience with Individualized Medicine (ATMP) is preferred
- Expert knowledge of Quality Assurance principles, practices and standards for the biopharmaceutical industry
- Expert knowledge of GMP relevant to the pharmaceutical industry; knowledge of the local and international GMP regulations
- Knowledge of existing and developing regulation related to ATMP