Senior Quality Control Director
4 weeks ago
Job Summary:
The Associate Director, Quality Control will lead all Quality Control aspects for GMP Operations in all phases of product development. This role will develop systems and procedures, build relationships with our CMO/CTO network, and serve as a subject matter expert (SME) for analytical and microbiology release assays.
Key Responsibilities:
- Establish and drive strategy to ensure we are ready and compliant with phase-appropriate - early to late-stage and commercial- Quality Control requirements at Avidity's CMOs/CTOs.
- Provide oversight of all QC activities at external CMOs/CTOs.
- Be the point of contact for all CMOs/CTOs from initiation of vendor contact through release and stability testing.
- Lead analytical technology transfers to CTOs and CMOs and interface with Avidity's analytical and process development teams to facilitate technology transfers.
- Enable testing activities within Avidity's CMO and CTO network to support release and stability of intermediates, drug substance, and drug product.
- Develop system and tools for ensuring supply of critical reagents, reference standards, and controls at CMOs/CTOs. Track inventory and burn rate.
- Develop systems/tools and database to track and review release and control data to ensure ease of data reporting and ensure appropriate analytical performance.
- Proactively identify and troubleshoot issues to prevent missed timelines and identify opportunities for improvement in QC operations at CMOs/CTOs.
- Drive from End-to-End deviation/OOS investigations as it relates to analytical and microbiological QC testing and implement CAPAs and change controls.
- Develop and track KPIs for external QC and CMOs/CTOs. Hold CMOs/CTOs accountable to deliver on contractual requirements and data delivery for release and stability testing.
- Work with QA to ensure CMOs and CTOs are audit ready, based on CMC milestones and program requirements.
- Communicate data both verbally at group meetings, CMC teams, and through written documents and reports.
- Author, review, and/or approve SOPs, policies, risk assessments, and technical reports.
- Support of cGMP operations, including technical review of change control documentation and reports, deviations, OOSs and other manufacturing and laboratory investigations.
- Work with project leads to address delays and escalate when necessary.
- Assist in the preparation of CMC regulatory submissions.
- Support other QC activities and projects as needed.
Requirements:
- BS or MS in Chemistry, Biochemistry, Microbiology, Biology, or other related field.
- 6+ years of related experience within the biopharmaceutical industry in QC management.
- Working knowledge of antibody, antibody drug conjugates, oligonucleotides, and protein analytical methods is strongly preferred.
- Demonstrated knowledge of cGMP/ICH/FDA/EU/PMDA regulations.
- Demonstrated knowledge of USP, EP, and JP monographs.
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
- A passion for addressing the critical unmet medical needs of patients.
- Self-directed individual who is able to work in a fast-paced, goal-oriented environment.
- Ability to organize data and identify gaps.
- Knowledge of Good Manufacturing Practices and Good Laboratory Practices.
- Experience of managing CMO relationships and projects.
- Experience with authoring IND/IMPD and BLA submissions.
- Sound understanding and demonstrated application of statistical methods/tools.
- Capable of strategic thinking that drives prioritization in the midst of a dynamic environment with multiple priorities.
- Excellent interpersonal skills, written and oral communication skills, and outstanding organizational skills.
What We Offer:
Avidity Biosciences offers competitive compensation and benefits, including the opportunity for annual and spot bonuses, stock options, and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD and four weeks of time off. A commitment to learning and development, including a variety of internal programming developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.
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