Quality Director (GMP)
Quality Director (GMP)
The Quality Director (GMP) will be responsible for strategic and operational management of the GMP and GLP QA activities at Cerevel. This role will have responsibility for providing QA oversight of GMP activities at Cerevel and its contract development and manufacturing organizations (CDMOs). This individual will provide technical quality expertise in the development and implementation of cGMP compliant quality systems, to ensure product quality, data integrity and most importantly, patient safety at Cerevel. This is a growth opportunity to define the GMP QA function at Cerevel to deliver high quality products in the clinical and commercial settings. In addition, this role will work closely with the GCP Quality function to develop Global Quality operations, which are inclusive of GxP SOP Management, CAPA and Deviation Management, product complaints, SOP and Quality-related training and Document Management.
- Capable of leading the team providing QA oversight for GMP/GLP activities at Cerevel and its contract development and manufacturing organizations (CDMOs).
- Ability to develop and implement risk-based Quality strategies for clinical and commercial products
- Proactively work with GCP Quality and Technical Operations staff to identify and mitigate quality risks within the company
- Develop processes for quality related requirements to enable the release and disposition of clinical and commercial products
- Develop, implement and maintenance of GMP/GLP Quality systems and procedures
- Ensure appropriate training of staff on GMP/GLP regulations and guidances
- Responsible for the auditing of CDMOs, providing recommendations and following up on corrective actions
- Provide Quality oversight to clinical and commercial distribution activities
- Lead preparations for CDMO inspection readiness
- Lead investigations and develop appropriate plans to resolve product related Quality issues including oversight of CAPAs, investigations, deviations, product complaints and recalls
- Develop metrics for GMP Quality at Cerevel and CDMOs and report results to senior management
- Ensure Technical Operations and CDMOs are compliant with global regulations, guidelines and industry standards
- Additional responsibilities as needed by a growing organization
- Minimum 10+ years of experience in GMP QA/GLP/QC/compliance areas
- Demonstrated experience to lead direct reports and teams
- Requires strong knowledge of regulatory inspections with experience in hosting
- Solid understanding of the regulatory climate related to GMP/GLP requirements
- Excellent knowledge of GMP/GLP compliance activities necessary for day-to-day operations of clinical and commercial supply operations
- Experience in developing and implementing GMP Quality systems
- Strong understanding of the R&D business; ability to partner with the business functions in order to enable high quality outcomes
- Strong project management, interpersonal, and communication skills
- Experience in managing contract development and manufacturing organizations
- Desire to work in a fast-pace, dynamic environment
- Excellent communication and presentation skills
- Team player; experienced at developing talent
- A high degree of autonomy; takes accountability for work
- Very organized and efficient; delivers high-quality work
Bachelor’s Degree or higher (Master’s or PhD preferred) in a life sciences-based discipline
An attractive compensation package commensurate with this management role will be provided.
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
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