What are the responsibilities and job description for the Associate Director, CGMP Quality Assurance position at People With Chemistry?
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 :
- 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.
KNOWLEDGE / SKILLS / ABILITIES :
EDCUATION & PROFESSIONAL EXPERIENCE :
The salary range for this position is $170,000 - $190,000. Base salary compensation is determined by a range of factors, including but not limited to candidate experience, qualifications, location and more.
Salary : $170,000 - $190,000
