Quality Assurance Director, GMP

Quality Assurance Director, GMP

W2 Contract

Salary Range : $187,200 - $208,000 per year

Location : Berkeley, CA - Hybrid Role

Job Summary :

In this role, you will oversee the daily quality review and approval of investigations, CAPAs, Change Controls, and related documentation.

You will also oversee qualifications and validations for computerized systems, software, enterprise systems, equipment, methods, and manufacturing processes.

Duties and Responsibilities :

Provide QA oversight of cGMP operations deviations, CAPAs, Change Controls, and qualification / validation at the manufacturing facility.

Drive for operational adherence to applicable cGMP regulations, company policies, and procedures.

• Provide direction to CMC Operations, Facilities, IT, QC, and QA teams for planned and unplanned deviations to resolve compliance issues and procedural errors, ensuring immediate actions are taken, assisting investigators on deviation strategy and documentation, reviewing and approving deviations, supporting identification of appropriate CAPA, and supporting site awareness / retraining following any events.
• Strategically identify, implement, and (as assigned) lead site-wide QA transformational programs and strategies in close partnership with Quality Systems, CMC Operations, Supply Chain and Quality Control to reduce deviations, improve right first time, improve quality record timeliness, identify and remediate trends, improve turnaround time (TAT), and prevent issues before they occur.
• Ensure timely Quality support and approval of GMP documentation, risk assessments, and change control impact assessments.
• Ensure the required processes, procedures, and systems are in place to enable compliant manufacturing, storage, and supply of products.
• Maintain a comprehensive understanding of process development, tech transfer, manufacturing, analytical development, QC testing processes, and the associated risk management control strategy to identify process risks and critical controls around the related processing steps.
• Effectively partner with CMC leadership to enhance quality mindset through timely, positive, constructive feedback and training.
• May act as a subject matter expert for GMP operations during audits and regulatory inspections. Contribute to the development and execution of the inspection readiness plan.

Support Health Authority interactions and ensure any regulatory observations are adequately addressed and completed on time.

• Work with the Quality Leadership Team to deploy a strategy for continuous improvement for quality oversite and QMS.
• Provide situational leadership and collaborate with internal and external teams.
• To assure continued compliance, provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal procedures.
• Perform due diligence activities and audits, internally and externally.

Requirements and Qualifications :

• Bachelor's degree in a relevant Science or Engineering discipline
• 15+ years of experience in managing Quality Assurance functions
• 7+ years of people management experience
• Expertise in Good Manufacturing Practices (GMP) related to Pharmaceutical, Biotech, and ATMP Manufacturing
• Experience implementing and overseeing GMP operations plant manufacturing for clinical and commercial biological / ATMP products at CDMOs.
• Knowledgeable of Digital Quality for IT systems and well-versed in FDA 21CFR Part 11 and EU Annex 11.
• Demonstrated excellence in written and verbal communication
• Able to work cross-functionally and to develop and maintain strong business partner relationships.
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment.
• Strong presentation and visual management capability
• Knowledge of performance measurement tools and metrics
• Good facilitation, change management, interpersonal and problem-solving skills
• Able to build solid and trusting relationships, lead large and complex programs, and work across divisions, diverse business backgrounds, and cultures.
• Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization
• Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end-to-end enterprise mindset) and makes the best decisions for the whole.
• Excellent influencing and negotiating experience and capabilities in a matrix environment
• Proven track record of delivering results and is action-oriented.
• Adaptable to changing work environments, work priorities, and organizational needs.
• Leads within the broader internal and external network and seeks to impact organization-wide performance.
• Embraces complexity but strives for simplicity.
• Translates the case for change into actionable and strategic plans for the organization

Preferred Qualifications :

• A background in Biologics or Cell Therapy Manufacturing is preferred.
• Expert-level expertise in Pharmaceutical Quality Management, Project Management, or Lean Six Sigma is strongly preferred.
• Experience in the management of large teams, including direct and indirect reports.
• Demonstrated experience building and leading exceptional teams
• Certified ASQ Auditor
• Open to occasional travel for vendor audits as needed

Desired Skills and Experience

Quality assurance, people management, Digital Quality, FDA 21 CFR part 11, EU annex 11, ASQ Auditor, Biologics, Cell Therapy Manufacturing, Pharmaceutical Quality Management, Project Management, Lean Six Sigma

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