Associate Director/Director, Quality Control

Job Title: Associate Director/Director, Quality Control

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week.

Role Overview:

The Associate Director/Director of Quality Control (QC) is responsible for providing quality control strategy, support, and oversight within a Phase 2 GMP biopharmaceutical manufacturing environment focused on monoclonal antibody production. This role ensures that all analytical testing, raw material and in-process controls, method qualification and execution, release activities, and stability programs are executed in compliance with current Good Manufacturing Practices (cGMP), regulatory expectations, and internal quality standards. The Associate Director/Director will partner closely with CMC, Quality Assurance, Upstream/Downstream Process Development, Analytical Development, Supply Chain, Clinical Operations, and Regulatory Affairs to support clinical supply, development of phase-appropriate QC Oversight Procedures and Processes, and future commercial readiness.

Key Responsibilities:

• Analytical Testing Oversight: Provide quality oversight of contract organization analytical testing, release testing, stability testing, microbiology, raw material release, and environmental monitoring programs. Participate in supplier qualification audits, due diligence site visits, and QC person-in-plant execution as needed.  Facilitate investigations for out-of-specification and/or out-of-trend results, external deviations, product complaints, and coordinate the necessary reviews and approvals.  Oversee qualification, validation, and lifecycle management of analytical methods used to test monoclonal antibody products.  Support tech transfer of analytical methods.  Establish relationships with contract manufacturing and testing organizations through on-site support (travel 20-25%).
• Establish a Robust Internal QC Infrastructure: Provide leadership to execute scaling QC capabilities for future late-phase/commercial manufacturing needs. Manage external testing laboratories, stability programs, specifications, analytical methods, reference standards, and critical reagents programs.  Develop phase-appropriate internal QC procedures and processes as pipeline continues to mature.  Own and manage Oruka LIMS system.  Establish and manage QC-related metrics.
• Ensure Uninterrupted Clinical Supply: Drive deviation investigations, out-of-specification (OOS) and out-of-trend (OOT) analysis, CAPA implementation, and change control within QC. Leverage stability data to project shelf-life of both DS and DP supply through trending analysis.  Manage product expiration dates and expiry extensions. Ensure timely review, approval, and trending of QC data to support product batch disposition and regulatory compliance.
• Support Clinical Program Advancement: Own QC-related regulatory submission content (e.g., IND amendments) and represent QC during audits and regulatory inspections. Contribute to scaling QC capabilities for future late-phase/commercial manufacturing needs.

Qualifications:

Required

• Bachelor’s degree in Life Sciences (e.g., Biochemistry, Biology, Chemistry) or related discipline; advanced degree preferred.
• 8+ years of experience in QC or analytical sciences within biopharmaceutical GMP environments, including monoclonal antibody testing.
• Experience in building and managing a QC team or group
• Proven experience in successfully standing up and managing contract laboratory vendors, including interfacing with new labs and negotiating quality agreements
• In depth knowledge of cGMP, FDA/EMA regulations, and applicable guidelines (e.g., ICH, WHO)
• Demonstrated expertise in biologics analytical methods (e.g., ELISA, CE-SDS, iCIEF, HPLC/UPLC, bioassays, cell-based assays, endotoxin testing, environmental monitoring).
• Experience with data integrity assessments or remediation within an organization or at a contract organization.
• Deep understanding of ICH guidelines for method development/qualification and validation as well as regulatory expectations in US, Canada, EU, etc.
• Experience with analytical method transfer and validation.
• Experience managing multiple stability studies, protocol development, stability trend analysis, OOS/OOT investigations, root cause analysis, etc.
• Strong analytical, investigative, and problem-solving skills, with the ability to design creative solutions to complex challenges.
• Excellent communication skills and the ability to lead cross-functional initiatives.
• Ability to work in a fast-paced, ever-changing environment, prioritizing and managing multiple tasks simultaneously.

Preferred

• Experience with combination device testing (e.g., pre-filled syringes, safety pre-filled syringes, autoinjectors).
• Experience with Stability/LIMS system management and implementation.
• Prior involvement in supporting regulatory inspections and authoring/reviewing regulatory submissions.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, Associate Director level is $175,000 - $200,000 and Director level is $205,000 - $230,000 The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

Job Location:

• Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week. 

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.