Director, GMP Quality Assurance (QA)

Tenaya is seeking a Director, GMP Quality Assurance (QA) to play a key quality leadership role in ensuring regulatory compliance during the cGMP manufacture of Tenaya products. This position will contribute to Tenaya’s success by managing GMP QA activities while working closely with cross functional team members. This position will also manage performance and development of direct reports to ensure achievement of organizational and department goals and a productive environment.

Specific responsibilities include:

Provide strategic leadership for GMP QA in support of current Good Manufacturing Practices (cGMPs) with significant operational and quality experience

Provide independent oversight and compliance direction for GMP Quality and product disposition, including Packaging Facility

• Drive process and product quality through effective quality systems
• Approve Protocol and Reports, Master Batch Records and Executed Batch Records for internal manufacturing and the Packaging at the contract manufacturing organization (CMO)
• Review and verify process data to assure compliance with data integrity and traceability regulatory requirements as appropriate
• Disposition (approve/reject) batches for clinical studies

Be a well-versed resource, with an ability to introduce Quality-relevant (phase appropriate) best practices into the CMC development processes

Develop and lead efforts for QA oversight of the manufacture of pre-clinical and clinical Drug Substance and Drug Product at CMO in partnership with Technical Operations, QC, Product Development, Supply Chain, and other relevant functions

Author/Review INDs and other relevant regulatory dossier sections based on area(s) of knowledge and expertise

Enable quality assurance processes for batch record review, deviation, change control and release testing review necessary to support drug product supply for clinical studies

Work in cross-functional teams as needed to lead site to a state of regulatory compliance

Work with cross-functional teams to conduct quality risk assessments, as required, for all aspects of the drug development process. Responsible for communicating Quality risks within the Quality organization

Oversee development and maintenance of internal manufacturing and operational SOPs related to GMP activities, with primary focus on cGMP regulations

Utilize GMP-regulated electronic quality management systems (eQMS) including document control, change control, deviations/complaints, DS/DP release and CAPAs

Coordinate with other departments within Tenaya to establish a robust QMS

Provide direct oversight of activities related to participation in U.S. FDA (CBER) and other regulatory agency inspections

Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.

Train and mentor junior staff; provide manufacturing site-wide GMP trainings as needed

Other duties as assigned

Requirements

• Bachelor’s degree in scientific discipline with experience in positions with management responsibility within Quality Assurance functions
• 10 years of experience in pharmaceutical or biotechnology operations, regulated life sciences, or quality assurance
• Proficient knowledge in CMC, Biologics, and experience in gene therapy is preferred
• Expert knowledge of quality risk assessment and management methodologies including successful application and risk remediation
• Experience directly managing individual contributors, project leaders, and people managers
• Proven ability to work proactively and think strategically, combining long-term vision with realizing the short-term business objectives
• Proven track record of cross-functional leadership in a highly dynamic environment, including leading teams through different stages of development and inspiring people
• Demonstrated ability to drive for results, lead innovation and manage change
• Superior problem-solving skills with proven abilities to resolve issues, anticipate issues and recommend effective, pragmatic and efficient solutions
• Demonstrated ability to build a strong network and manage stakeholder and senior management relationships
• Excellent management skills, with a strong focus on continuous learning and developing talent & motivating staff
• Excellent facilitation skills, verbal and written communication skills with success in influencing others in cross-functional areas
• Excellent computer proficiency (MS Office applications, Microsoft Project, Adobe PDF)

Benefits

We offer a dynamic start-up environment and a collaborative, passionate team that is focused on a compelling vision and mission.

We offer competitive salary and stock options. Excellent medical and non-medical benefits. Paid vacation, sick time and holidays.

State-of-the-art, built-to-suit office and lab space, part of a larger cluster of biotech companies, with amenities that include a bowling alley and onsite gym.

Shuttle service to/from Caltrain, BART and the South San Francisco Ferry.

Tenaya is proud to be an equal opportunity workplace.