Associate Director, Quality Control
Reports to: Senior Director, Quality Operations, CMC
Location: This position may be performed remotely with travel to the Boston area as needed.
Position Summary
Praxis is seeking a highly experienced, motivated, and innovative quality leader with strong experience in late-stage development and commercialization to join our Quality team as Associate Director, Quality Control to support QC product release and stability activities. Reporting to Senior Director, Quality Operations CMC, this position will be responsible for managing and executing Quality Control activities in support of product testing, release, and stability, and toxicology studies test material inventory support. Ensure GMP activities are conducted in accordance with applicable SOPs, compendia, approved methods, and in accordance with company's and regulatory agencies' policies and procedures.
Primary Responsibilities
- Quality control oversight of contract lab activities e.g. routine testing, testing results review and approval, generation of Certificate of Analysis, review/approval of technical documents such as method validation and qualification protocols/reports, and regulatory filing documents per project needs as required
- Manage and lead clinical and commercial quality control compliance for stability, reference standard, and specification programs
- Support the establishment of QC systems such as product specifications, product expiry, reference standard program, QC documentation including SOP's, material specifications and other quality documents, etc.
- Support CMC Analytical Development in a QC aspect by review and approval of applicable documents in support of activities such as method development, transfer, characterization, comparability investigations, analytical test method qualification plans/protocols and reports
- Perform data review of trending for in-process testing, release, and stability and identify data trends, to ensure compliance with regulatory filings and ICH or other global health authority guidance documents, as applicable
- Support technology transfer and process performance qualification with product characterization/process validation activities
- QC support in the generation, quality, and compliance review of bioanalytical data from preclinical and clinical projects for proprietary compounds and in some cases support for sample analysis projects
- Support tox material inventory monitoring process, to ensure no impediments to completing studies
- Additional responsibilities and ad hoc projects as required
Qualifications and Key Success Factors
- Bachelors degree strongly preferred, with minimum of 6 years of experience in cGMP Quality Control environment
- In-depth technical and regulatory understanding of GMP biologics manufacturing and testing including applicable international regulations/standards (GMP and ICH guidelines) in all phases of product development and commercialization
- Experience managing third party assay laboratories, collaborations, and relevant bioanalytical vendors preferred
- Extensive knowledge of GMP regulations, ICH guidelines, and stability testing requirements.
- Proven track record of managing stability programs and COA processes for clinical and commercial products
- Experience working in QC lab environment with hands-on experience in running, qualifying, and validating analytical methods
- Ability to work effectively in a fast-paced, dynamic environment
- Experience managing Contract Test Labs activities
- Experience with regulatory inspections and interactions with health authorities
- Excellent communication skills and ability to build key networks and business relationships across all levels of the business