Associate Director, Quality Control

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee quality control for contract laboratory activities, including routine testing, reviewing and approving testing results, generating Certificates of Analysis, and reviewing/approving technical documentation such as method validation and qualification protocols/reports, as well as regulatory filing documents based on project requirements.

• Lead and manage compliance for clinical and commercial quality control concerning stability, reference standard, and specification programs.

• Assist in establishing QC systems including product specifications, product expiry dates, reference standard programs, and QC documentation such as SOPs, material specifications, and other quality-related documents.

• Support CMC Analytical Development by reviewing and approving relevant documents in relation to activities like method development, transfer, characterization, comparability investigations, and analytical test method qualification plans/protocols and reports.

• Conduct data reviews for trending in-process testing, release, and stability to identify trends and ensure compliance with regulatory filings and guidance documents from ICH or other global health authorities, as applicable.

• Assist with technology transfer and process performance qualifications alongside product characterization and process validation activities.

• Provide QC support in generating, reviewing, and ensuring the quality and compliance of bioanalytical data from preclinical and clinical projects for proprietary compounds, and occasionally support sample analysis projects.

• Aid in monitoring the inventory of toxic materials to prevent any delays in study completion.

• Undertake additional responsibilities and ad hoc projects as needed.

⛳️ Requirements

• A Bachelor's degree is strongly preferred, along with a minimum of 6 years of experience in a cGMP Quality Control environment.

• Comprehensive technical and regulatory knowledge of GMP biologics manufacturing and testing, including relevant international regulations and standards (GMP and ICH guidelines) across all product development and commercialization phases.

• Preferred experience in managing third-party assay laboratories, collaborations, and relevant bioanalytical vendors.

• Extensive understanding of GMP regulations, ICH guidelines, and stability testing requirements.

• Proven experience in managing stability programs and Certificate of Analysis processes for clinical and commercial products.

• Hands-on experience in a QC lab environment, including running, qualifying, and validating analytical methods.

• Capability to operate effectively in a fast-paced, dynamic environment.

• Experience overseeing activities in Contract Test Labs.

• Familiarity with regulatory inspections and interactions with health authorities.

• Strong communication skills and the ability to build essential networks and business relationships across all organizational levels.

🏝️ Benefits

• Coverage of 99% of premium costs for medical (Blue Cross Blue Shield), dental, and vision plans.

• A bonus program designed to pay out quarterly.

• A 401k plan featuring a 100% match up to 6% of the employee’s contribution (Traditional & Roth).

• A wellness benefit of $200/month towards a wide range of flexible options, including travel, fitness equipment & memberships, student loan repayment, sports fees, and more.

• Unlimited PTO, two weeklong shutdowns each year, and a generous extended family leave benefit.

• Eligibility for equity awards and an Employee Stock Purchase Plan (with a 15% discount).