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Associate Director, CGMP Quality Assurance
159757
Posted:
06/02/2025
- 170000 USD - 190000 USD
- San Francisco , United States
- Permanent
Electra Therapeutics, based in South San Francisco, California, is a clinical stage biotechnology company developing therapies that target signal regulatory proteins (SIRP) for the treatment of immunological diseases and cancer.
The Associate Director of CGMP Quality Assurance will report to the Head of Quality and work with cross-functional teams to manage external vendors and CDMOs. The role involves providing quality support and contributing to the development of Electra’s quality systems. Expertise in GMP and related regulations is required, with a focus on maintaining high standards and promoting a culture of ethics, integrity, and proactive quality management.
RESPONSIBILITIES:
The Associate Director of CGMP Quality Assurance will report to the Head of Quality and work with cross-functional teams to manage external vendors and CDMOs. The role involves providing quality support and contributing to the development of Electra’s quality systems. Expertise in GMP and related regulations is required, with a focus on maintaining high standards and promoting a culture of ethics, integrity, and proactive quality management.
RESPONSIBILITIES:
- Serve as the technical expert on CGMP-related regulations and guidelines, specifically for manufacturing, testing, and controls.
- Review and approve drug substance and drug product manufacturing, packaging, and labeling documents within defined timelines.
- Lead and support external quality activities, including batch record reviews, analytical method validations, tech transfers, deviations, quality agreements, supplier qualifications, and audits.
- Participate in CDMO team meetings, providing quality feedback and collaborating on complex investigations for Electra’s global product network.
- Ensure collection, review, and analysis of data for internal and external metrics.
- Offer guidance, review, and impact assessments for change controls and CAPAs.
- Assist in the implementation of CGMP and GLP activities in line with internal procedures and regulatory requirements.
- Participate in quality system and product review meetings, providing quality reviews of key CMC and IND documents and ensuring data integrity compliance.
- Represent Quality on project teams, Health Authority Inspections, supplier and CDMO meetings, and QA to QA discussions.
- Work with Quality Person (QP) to support key document development and approval.
- Opportunity to gain hands-on experience with GCP-focused projects, including the potential to participate in auditing activities.
- Foster a strong quality mindset and excellence across the organization.
- Lead and promote a culture of collaboration, aligned with Electra’s core values.
- Strong decision-making skills in complex supply, compliance, technical, and regulatory situations; adept at managing ambiguity.
- Hands-on experience in manufacturing, analytical testing, and development.
- Proven track record in working with suppliers and CDMOs.
- Expertise in implementing and managing Quality Management Systems, including paper-based and Celito EDMS in biotech/pharma.
- In-depth knowledge of FDA, EMA, ROW CGMP regulations, and ICH guidance.
- Experienced in developing Quality Management Systems (QMS) and enjoys interpreting regulations to build and maintain compliant systems.
- Excellent verbal and written communication skills.
- Strong collaborative, analytical, and interpretative abilities.
- Self-sufficient with the ability to prioritize and meet deadlines.
- Experience working with cross-functional teams.
- Some travel required (around 10%).
- Bachelor’s or advanced degree in Biology, Chemistry, Chemical Engineering, or related scientific field.
- Minimum 5 years of CGMP Quality Assurance experience.
- Knowledge in clinical development to commercial is desired (ideally phase II/III to commercial).