Director, Quality Control

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

📋 Description

• Oversee quality and technical governance for all QC activities, including raw materials, in-process testing, release, stability, and special testing for drug substances, drug products, and combination devices.

• Ensure that QC laboratories and operations are compliant with relevant regulations and internal standards.

• Serve as the main escalation point for critical QC-related quality and compliance issues.

• Provide quality oversight and approval for Laboratory Investigations (including OOS, OOT, atypical results, deviations, and data integrity events), ensuring investigations are scientifically valid, risk-based, appropriately escalated, trended for systemic issues, and supported by effective CAPAs until closure.

• Analyze QC events to identify and address systemic issues.

• Establish and manage lifecycle processes for reference standards and critical reagents, collaborating with Analytical Development to define qualification strategies, potency assignments, and requalification methods, ensuring consistent application across internal QC labs and external testing partners.

• Oversee the global stability program's quality and lifecycle, including protocol design, execution oversight, data review and interpretation, trend analysis, and reporting, ensuring stability studies back regulatory filings, shelf-life assignments, and continuous product verification.

• Provide oversight for annual product quality reviews related to QC data (e.g., OOS/OOT trends, stability data, CoAs/QC release testing).

• Ensure robust processes for CoA generation, review, and approval for clinical and commercial materials, guaranteeing analytical data integrity, specification compliance, and alignment with regulatory filings.

• Manage specification processes, including establishment, review, approval, and lifecycle maintenance for drug substances, drug products, and combination devices in partnership with Pharmaceutical Sciences.

• Ensure that scientific justifications and regulatory rationales are aligned, verifying that specifications are scientifically validated, phase-appropriate, and in accordance with regulatory commitments.

• Collaborate with Regulatory Affairs to support specification-related regulatory submissions and variations.

• Provide quality and technical oversight for analytical method validation, verification, lifecycle management, and method transfers in close cooperation with Analytical Development, including reviewing validation designs, acceptance criteria, and method performance trends.

• Ensure that methods are robust, controlled, and compliant across external testing sites.

• Lead or assist in Quality Assurance (QA) audits and regulatory inspections of QC laboratories, acting as a Quality Subject Matter Expert (SME).

• Ensure that inspection observations, audit findings, and regulatory commitments are effectively addressed and maintained.

• Define QC-related processes within the Quality Management System (QMS), including SOPs, training, change control, and risk management.

• Drive continuous improvement initiatives across QC processes, analytical efficiency, and compliance maturity.

• Contribute QC metrics, trends, and risk assessments to Quality Management Review (QMR) and Quality Council forums.

• Provide functional leadership, mentoring, and development for QA staff involved in QC oversight.

• Support the selection, qualification, and ongoing oversight of external QC laboratories and CMOs.

⛳️ Requirements

• An advanced degree in Chemistry, Pharmaceutical Sciences, Biology, Engineering, or a related scientific discipline (MS/PhD preferred).

• A minimum of twelve (12) years of quality experience in pharmaceutical or biotechnology settings, with considerable experience in QC, QA oversight of QC, and/or analytical sciences.

• Proven experience in supporting small molecule, biologics, and/or combination device programs.

• Strong working knowledge of FDA, EMA, ICH, EU GMP, and global regulatory expectations for laboratory operations.

• Demonstrated experience in supporting regulatory inspections and managing complex QC-related compliance challenges.

• A solid understanding of risk management fundamentals and tools.

• Experience in statistical analysis of analytical data and method capability, with strong scientific and analytical judgment.

• A deep understanding of laboratory investigations and data integrity.

• Proven ability to apply scientific judgment to the interpretation of analytical data, method performance issues, and complex laboratory investigations.

• Excellent organizational skills with the ability to manage multiple projects under tight timelines.

• Exceptional communication, negotiation, and presentation skills; maintains high ethical standards and enjoys collaborating with others, problem-solving, and making impactful decisions in a leadership capacity.

• Demonstrated capability to work effectively in cross-functional teams as well as independently in a remote work environment, as needed.

• Strong problem-solving and decision-making abilities.

🏝️ Benefits

• Health insurance

• Flexible working arrangements

• Professional development opportunities