Associate Director, QC Analytical Lifecycle Management

Brief Job Profile Description

The Associate Director, QC Analytical Lifecycle Management provides strategic and technical leadership for analytical activities supporting GMP manufacturing, in-process and final product testing, analytical method lifecycle management, and clinical and commercial laboratory readiness.

The role leads the transfer, qualification, validation, verification, implementation, troubleshooting, performance monitoring, continuous improvement, and retirement of analytical methods used for raw materials, in-process samples, release testing, stability testing, and characterization, as applicable.

The position partners across Quality Control, Analytical Development, Manufacturing, Quality Assurance, Process and Equipment Validation, Regulatory CMC, Supply Chain Planning, External Quality and Supply, and external testing laboratories to establish robust, phase-appropriate, and compliant analytical capabilities.

The role provides scientific direction for complex investigations and technical decisions, influences cross-functional teams and governance, and develops analytical technical operations capability in alignment with patient safety, product quality, compliance, supply, and business needs.

Typical Accountabilities

• Provide strategic, scientific, and operational leadership for GMP analytical technical operations supporting manufacturing, in-process and final product testing, analytical method lifecycle management, and clinical and commercial laboratory readiness.

• Lead analytical method transfer, qualification, validation, verification, implementation, troubleshooting, lifecycle management, performance monitoring, continuous improvement, and retirement in accordance with approved procedures and regulatory expectations.

• Establish technical strategies for analytical readiness, including laboratory capability, instrumentation, materials, reference standards, reagents, methods, documentation, data systems, training, and external laboratory support.

• Provide technical oversight and scientific direction for complex laboratory investigations, out-of-specification and out-of-trend results, method-related deviations, and analytical risk assessments.

• Support quality records associated with analytical method lifecycle management, including deviations, CAPAs, change controls, and risk assessments, within assigned authority and applicable procedures.

• Serve as a key analytical technical interface across Quality Control functions, Analytical Development, Manufacturing, Quality Assurance, Process and Equipment Validation, Regulatory CMC, Supply Chain Planning, External Quality and Supply, and site and network partners.

• Ensure analytical methods and associated control strategies are scientifically sound, fit for intended use, appropriately validated, and compliant with GMP, data integrity principles, relevant pharmacopeias, approved procedures, and applicable regulatory commitments.

• Lead assessments of method performance and laboratory trends, identify emerging risks, and implement sustainable improvements that strengthen robustness, efficiency, right-first-time execution, and inspection readiness.

• Author, review, and approve protocols, reports, procedures, technical assessments, specifications, validation documentation, regulatory-supporting content, and other GMP records within assigned authority.

• Support regulatory submissions, health authority questions and inspections, internal and external quality audits, and regulatory commitments by providing clear technical rationale, documentation, and subject matter expertise.

• Develop and manage program plans, priorities, resources, timelines, metrics, and governance to deliver analytical activities in alignment with manufacturing schedules and business objectives.

• Provide analytical technical expertise for raw-material testing, extended characterization, and external testing laboratories when required by product, program, or laboratory needs.

• Provide technical governance and performance oversight for external laboratories, including alignment on technical expectations, issue escalation, and delivery requirements, in partnership with accountable Quality and Supply functions.

• Influence and align cross-functional teams and technical stakeholders; lead, coach, and develop analytical technical operations professionals as organizational scope and staffing require.

• Maintain awareness of current regulatory and industry standards, including relevant pharmacopeial requirements, FDA and other health authority guidance, ICH guidance, and industry best practices.

• Make timely, risk-based decisions in a matrix environment, including when information is incomplete or timelines are constrained, while maintaining patient safety, product quality, and compliance as primary priorities.

• Perform other duties, as appropriate.

Qualifications and Skills

Essential

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biological Sciences, Engineering, or a related scientific discipline.

• 8+ years of relevant experience in biopharmaceutical, biotechnology, medical device, or pharmaceutical development, manufacturing, or Quality Control; 6+ years with an advanced degree such as an MS or PhD.

• 2+ years of managerial, supervisory, or substantial technical team leadership experience.

• Extensive experience with GMP analytical testing and analytical method lifecycle activities, including method transfer, qualification, validation, verification, implementation, troubleshooting, and performance monitoring.

• Demonstrated technical depth in one or more analytical areas relevant to the product portfolio, such as compendial testing, chromatography, spectroscopy, potency, purity, identity, molecular methods, microbiological methods, cell-based assays, or other advanced analytical technologies.

• Experience leading laboratory investigations and supporting deviations, CAPAs, change controls, risk assessments, and data review in a regulated environment.

• Working knowledge of GMP requirements, data integrity principles, ICH guidance, relevant pharmacopeias, and FDA or other global health authority expectations for analytical methods and laboratories.

• Demonstrated ability to lead in a matrix environment, influence cross-functional decisions, and communicate complex technical topics effectively to laboratory staff, peers, senior management, auditors, and regulatory stakeholders.

• Strong organizational, strategic planning, problem-solving, and decision-making skills, with the ability to manage multiple priorities and deliver compliant results under demanding timelines.

• Ability to make effective, risk-based decisions in the absence of complete information and when under pressure.

Desirable

• Experience supporting technology transfer, product introduction, laboratory start-up or readiness, commercial manufacturing, regulatory submissions, inspections, or external laboratory oversight.

The annual base pay (or hourly rate of compensation) for this position ranges from $135,463.20 to $203,194.80. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.