Director, Quality Control

Job Title: Director, Quality Control

Location: Hybrid – Waltham, MA or Menlo Park, CA.  Candidates will be required to be in-office 3 days/week   Open to remote for non-local candidates.

Role Overview:

The Director, Quality Control – Combination Products will provide strategic and operational leadership for the Quality Control function supporting late-stage clinical development, analytical testing oversight for clinical drug substance and drug product, process performance qualification (PPQ), regulatory submissions, and commercial launch readiness for monoclonal antibody drug products and combination products, including pre-filled syringes and autoinjectors.  This role will ensure timely, compliant, and scientifically sound oversight of release, stability, characterization, in-process, and method lifecycle activities performed at CMOs and contract testing laboratories.

This role is responsible for ensuring that all QC systems, analytical methods, and testing programs are inspection-ready and aligned with global regulatory expectations for commercial biologics. The Director will partner cross-functionally and externally to enable successful PPQ execution, analytical method validation, regulatory approval, and commercial launch readiness.

Key Responsibilities:

QC Strategy, Clinical Execution & Commercial Readiness

• Develop and execute the enterprise QC strategy to support clinical product testing, Phase 3 clinical trials, PPQ, BLA submission, and commercial launch.
• Build scalable QC systems, processes, governance, and organizational capabilities aligned with commercial-stage operations.
• Establish and maintain analytical control strategies for drug substance (DS), drug product (DP), and combination products.
• Ensure inspection readiness across QC operations, documentation, data integrity, and external partner networks.
• Serve as a strategic advisor to Quality and CMC on analytical and QC-related risks, compliance considerations, and commercialization readiness.

Analytical Methods, Validation & Lifecycle Management

• Lead and provide oversight of analytical method qualification, validation, transfer, verification, and lifecycle management in alignment with ICH, FDA, EMA, and global regulatory expectations.
• Ensure all release, characterization, and stability-indicating methods are validated and commercially sustainable prior to BLA submission.
• Oversee analytical comparability strategies, method bridging activities, and technology transfers across CMOs and contract laboratories.
• Drive continuous improvement of analytical control strategies and testing programs through data trending and lifecycle management principles.
• Ensure effective governance of reference standards, critical reagents, and assay performance monitoring programs.

PPQ, Validation & Continued Process Verification

• Partner cross-functionally with Manufacturing, MSAT, and CMC teams to ensure QC readiness for PPQ execution and commercial manufacturing.
• Provide QC oversight for in-process, release, and stability testing supporting validation campaigns and commercial supply.
• Support continued process verification (CPV) programs through statistical trending, data analysis, and ongoing monitoring of product quality attributes.
• Ensure timely and compliant batch disposition support through robust data review and issue escalation processes.

Combination Product Quality Control Leadership

• Lead QC strategy and oversight for combination products, including pre-filled syringes, autoinjectors, and device constituent components.
• Ensure compliant testing strategies for container closure integrity, product-device compatibility, particulate matter, functionality, and device-related attributes.
• Oversee QC support for extractables and leachables (E&L), shipping validation, and stability programs associated with delivery systems.
• Ensure QC operations and external partners comply with applicable combination product regulations, including 21 CFR Part 4 and relevant global guidance.
• Support commercial readiness and lifecycle management for combination product manufacturing and release.

Clinical Product Analytical Testing Oversight and External Laboratory Management

• Provide QC oversight for analytical testing of clinical drug substance and drug product, including release, stability, in-process, characterization, and comparability testing.
• Provide oversight of contract testing laboratories and CMOs, including selection, qualification, governance, performance management, and risk mitigation.
• Establish and maintain Quality Agreements and analytical governance structures aligned with commercial and regulatory expectations.
• Lead oversight activities during critical manufacturing campaigns, investigations, audits, and inspection preparation activities.
• Drive accountability and performance across the external analytical network to ensure reliable execution and compliance.
• Investigations, Compliance & Quality Systems
• Lead complex investigations involving OOS, OOT, deviations, laboratory events, complaints, and analytical discrepancies.
• Ensure robust root cause analysis, effective CAPA implementation, and sustainable compliance solutions.
• Champion data integrity principles (ALCOA+) and ensure compliance across QC systems, laboratories, and third-party partners.
• Establish meaningful QC metrics, dashboards, and management review processes to drive operational excellence and continuous improvement.

Regulatory & Inspection Support

• Author, review, and approve QC-related sections of regulatory submissions, including analytical methods, specifications, validation reports, comparability assessments, and stability data.
• Serve as the QC Subject Matter Expert during regulatory inspections, pre-approval inspections (PAIs), and partner audits.
• Lead responses to health authority questions, observations, and deficiency letters related to analytical and QC activities.
• Maintain current knowledge of evolving global regulatory expectations for biologics and combination products.

Qualifications:

Required

• Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related scientific discipline; advanced degree preferred.
• 10+ years of progressive Quality Control and analytical experience within GMP biopharmaceutical environments, including late-stage clinical and commercial readiness activities.
• Experience overseeing GMP analytical testing for clinical-stage biologic DS and DP, including release, stability, in-process, and/or comparability testing performed by CMOs or contract testing laboratories.
• Demonstrated experience supporting BLA and/or MAA submissions, regulatory inspections, and commercial launch preparation.
• Deep expertise in biologics analytical methods, including chromatographic, electrophoretic, cell-based, compendial, and microbiological techniques.
• Extensive experience with analytical method validation, lifecycle management, comparability, and technology transfer.
• Strong knowledge of cGMP regulations and global regulatory expectations, including 21 CFR Parts 210, 211, and 4.
• Hands-on experience supporting combination products such as pre-filled syringes, autoinjectors, or related delivery systems.
• Proven success leading QC support for PPQ campaigns, validation activities, and commercial manufacturing readiness.
• Demonstrated experience managing CMOs, contract laboratories, and global external testing networks.
• Strong understanding of data integrity principles, electronic systems, and QC compliance requirements.
• Proven ability to build and scale Quality organizations in a fast-paced biotech environment.
• Excellent leadership, communication, and cross-functional collaboration skills with the ability to influence at all organizational levels.

Preferred

• Direct experience supporting successful BLA approval and commercial product launch.
• Experience in a rapidly growing biotechnology company transitioning to commercial operations.
• Knowledge of extractables/leachables, container closure systems, and device constituent testing.
• Experience implementing or optimizing LIMS, stability systems, and digital QC infrastructure.
• Experience supporting global regulatory filings and international commercialization activities.

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 is $213,000 - $240,000. 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.

 Location: Hybrid – Waltham, MA or Menlo Park, CA.  Candidates will be required to be in-office 3 days/week   Open to remote for non-local candidates

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.