Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
DESCRIPTION:
At Thermo Fisher Scientific, you'll lead and own the site quality strategy, sterility assurance framework, and Pharmaceutical Quality System (PQS) execution for a multi-platform CDMO manufacturing site producing both sterile and Oral Solid Dose (OSD) products. As the Site Quality Head, you'll be the independent Quality authority on the Site Leadership Team and hold ultimate responsibility for ensuring that all products manufactured, tested, and released from the site meet global regulatory requirements and Thermo Fisher Scientific quality standards.
The role requires strong leadership capability across both aseptic/sterile manufacturing and OSD operations, ensuring patient safety, product quality, regulatory compliance, inspection readiness, and reliable delivery across platforms including aseptically manufactured injectables and devices, and OSD products such as tablets, capsules and granules.
How you will make an impact:
- Establish and implement an integrated site quality strategy aligned with business objectives, global regulatory expectations, and Thermo Fisher Scientific quality standards across both Sterile and OSD operations.
- Represent Quality as a core member of the Site Leadership Team and ensure quality and patient-safety considerations are embedded in strategic and operational decision making.
- Promote a proactive, patient-first quality culture focused on compliance, risk management, operational excellence, and continuous improvement.
- Ensure the effectiveness of the site Pharmaceutical Quality System and drive risk-based decision making across all manufacturing platforms.
- Define and govern the site sterility assurance framework, including the contamination control strategy (CCS), and ensure compliance with EU GMP Annex 1 requirements for aseptic process integrity.
- Provide Quality oversight for OSD manufacturing processes and associated critical quality controls, including granulation, compression, coating, blend/content uniformity, dissolution, stability, and cleaning validation.
- Ensure full compliance with applicable global regulatory requirements, including FDA 21 CFR Parts 210 and 211, EU GMP, ICH guidelines, and other relevant global standards, while maintaining continuous inspection readiness.
- Hold final Quality authority for batch disposition and product release decisions across both Sterile and OSD products.
- Serve as the senior Quality interface for regulatory authorities and CDMO customers, including customer audits, regulatory submissions, inspections, commitments, and remediation activities.
- Lead and develop the site Quality organization, building high-performing teams, strong succession pipelines, and capability to support both sterile and OSD manufacturing excellence.
What you will do:
- Lead the site Quality function and provide clear governance, priorities, resources, and decision-making standards across Sterile and OSD Quality teams.
- Lead regulatory inspections, including FDA, EMA, and all applicable, and own site responses to observations, commitments, remediation programs, and regulatory follow-up.
- Provide governance for sterility assurance programs including environmental monitoring, cleanroom management, aseptic process simulations/media fills, operator qualification, contamination control, and aseptic process validation.
- Provide appropriate Quality governance and approval of validation strategies, protocols, and reports supporting aseptic processing, OSD manufacturing, cleaning, process validation, qualification, and computer system compliance.
- Ensure robust Quality oversight of OSD manufacturing controls, including granulation, compression, coating, blend and content uniformity, dissolution testing, stability programs, and cleaning validation lifecycle.
- Ensure effective management of the site PQS, including deviations, investigations, CAPA, change control, complaints, document control, product quality review, and escalation of significant quality events.
- Apply risk-based decision making aligned with ICH Q9 and ICH Q10 quality management principles and ensure strong root-cause analysis and corrective/preventive action effectiveness.
- Ensure site compliance with global data integrity expectations aligned with ALCOA+ principles and maintain appropriate governance of quality management and computerized systems.
- Exercise independent Quality authority to halt manufacturing, testing, release, or distribution when product quality, patient safety, or compliance risk is identified.
- Maintain strong partnerships with Operations, Technical, Development, Supply Chain, Commercial, and other site leadership functions while preserving independent Quality decision making.
- Establish and monitor a balanced site quality performance framework, including regulatory inspection outcomes, environmental monitoring trends, media fill performance, batch quality performance, deviation and CAPA cycle times, audit performance, and supplier quality performance.
- Lead quality transformation and continuous improvement initiatives that strengthen quality culture, compliance maturity, process robustness, and organizational effectiveness across both manufacturing platforms.
REQUIREMENTS:
How you will get here:
- Bachelor's or advanced degree in Life Sciences, Microbiology, Pharmacy, Pharmaceutical Sciences, Engineering, or a related field.
- A minimum of 12 years of pharmaceutical manufacturing experience, including significant leadership roles in Quality within regulated manufacturing environments.
- Demonstrated Quality leadership experience across both sterile/aseptic and Oral Solid Dose (OSD) manufacturing operations, with the capability to lead teams responsible for both platforms.
- Extensive knowledge of aseptic processing, sterility assurance, contamination control strategy, and EU GMP Annex 1 requirements.
- Strong knowledge of OSD manufacturing processes and critical controls, including granulation, compression, coating, blend/content uniformity, dissolution, stability, cleaning validation, and process validation.
- Comprehensive knowledge of cGMP and global regulatory requirements, including FDA, EMA, MHRA, WHO and relevant ICH expectations.
- Demonstrated experience leading regulatory inspections, customer audits, and complex compliance or remediation situations.
- Expertise in managing Pharmaceutical Quality Systems including CAPA, change control, deviations, complaints, document control, and quality risk management.
- Strong understanding of risk management methodologies and quality tools, including practical application of ICH Q9 and ICH Q10 principles.
- Expertise in validation, qualification, cleaning validation, and computer system compliance, with strong understanding of data integrity expectations.
- Proficiency in root-cause analysis, investigation quality, implementation and effectiveness verification of corrective and preventive actions.
- Proven experience leading, developing, and succession-planning for high-performing Quality teams in a pharmaceutical manufacturing environment.
- Strong written and verbal communication skills, with the ability to collaborate effectively across all organizational levels, regulatory authorities, and CDMO clients.
- Strong project management, problem-solving, and continuous improvement capabilities.
- Experience with electronic quality management systems and quality performance metrics.
- Experience in a CDMO or similarly customer-facing pharmaceutical manufacturing environment is strongly preferred.
- Travel up to 20% as required.
