Associate Director, Quality Control

Jobtailor; Boston (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Jobtailor, based in Boston, seeks an experienced Quality Control Leader to drive clinical and commercial drug substance and drug product QC activities in line with ICH and cGMP. You will oversee stability programs, master specifications, and release testing across API and drug products.

This role requires collaboration with QA, external labs, CMOs, and cross-location teams, leading investigations (OOS/OOT), CAPAs, and audits. Travel up to 20% and onsite presence at Boston office 2 days/week.

Qualifications

• Undergraduate degree in life sciences.
• 8+ years of relevant management experience in the pharmaceutical industry.
• Experience with small molecules and/or biologics.
• Experience working with external testing laboratories.
• Ability to work independently and influence in a fast-paced environment.
• Strong quality mindset.
• Travel up to 20% domestically and internationally.
• Willingness to work onsite at the Boston office at least 2 days per week.

Responsibilities

• Lead Quality Control activities supporting clinical and commercial drug substance and drug product programs per ICH and cGMP.
• Manage master specifications for starting materials, reference standards, API, and drug products.
• Lead stability activities, including trending, evaluation, shelf-life extensions, and risk evaluation.
• Lead OOS and OOT investigations and draft reports with internal teams and external labs.
• Review and manage analytical and non-analytical results for release and stability.
• Coordinate audits of external laboratories and CMOs; conduct remote/onsite audits as needed.
• Collaborate with QA on release documents (COA/Certificate of Testing) and with Drug Product/API groups on trial material deliverables.
• Support transfer of new drug candidates to CMC development; oversee tech transfers and sample movement.
• Ensure deviations, change controls, and CAPAs are properly managed.

Skills

Quality Control Leadership

Stability Program Management

OOS/OOT Investigations

Regulatory Knowledge (ICH, cGMP)

External Lab Collaboration

Team Leadership

CAPA Management

Written & Verbal Communication

Education

Undergraduate degree in life sciences

Tools

Quality Management Systems

Method Validations

Master Specifications

Job description

• Lead Quality Control activities supporting clinical and commercial drug substance and drug product programs in accordance with ICH and cGMP requirements
• Manage master specifications for starting materials, reference standards, API, and drug products
• Lead stability activities, including trending, statistical evaluation, scientific interpretation, shelf-life extensions, expiry dating justifications, and emerging risk evaluation
• Manage stability studies and monitor stability data for reference standards, API, and drug products
• Lead OOS and OOT investigations and draft reports with internal teams and external testing laboratories
• Review and manage analytical and non-analytical results for product release and stability
• Organize and file quality control data, protocols, and reports
• Manage reference standard qualification and distribution through external laboratories
• Lead quality control checks on CMC sections of IND, CTA, and NDA submissions
• Manage review and approval workflows for feasibility/comparability studies, validation protocols and reports, and test methods
• Collaborate with QA on release documents, including Certificates of Analysis and Certificates of Testing
• Manage relationships with external laboratories and CMOs; participate in remote audits and perform onsite audits as required
• Collaborate with Drug Product and API groups to optimize clinical trial material deliverables
• Support transfer of new drug candidates from research/discovery to CMC drug development
• Oversee sample movement between testing partners and CMOs for tech transfers, release, and stability testing
• Assess team capacity and lead assigned teams to meet project deliverables, including performance reviews
• Ensure compliance with deviations, change controls, and CAPAs
• Recruit, lead, develop, coach, and evaluate direct reports as applicable
• Ensure adherence to company policies and Code of Business Conduct and Ethics
• Travel internationally as required

Requirements

• Undergraduate degree in life sciences
• 8+ years of relevant management experience in the pharmaceutical industry
• Experience with small molecules and/or biologics
• Experience working with external testing laboratories
• Ability to work independently and influence in a fast-paced environment
• Strong quality mindset
• Comfort working across locations and time zones
• Strong experience with quality control testing
• Experience managing stability programs in accordance with ICH guidelines
• Experience with master specifications
• Experience with method validations
• Experience with OOS/OOT investigations
• Experience with batch release processes
• Experience with quality management systems
• Experience auditing external laboratories, FDA/EMA inspections, and inspection readiness preferred
• Prior experience with IND, BLA, and/or CTA CMC submissions preferred
• Knowledge of cGMP and US, Canadian, and EU regulatory environments
• Excellent oral and written communication skills
• Previous team leadership experience
• Willingness to travel up to 20% domestically and internationally
• Ability to work onsite at the Boston office at least 2 days per week

Core Competencies

Demonstrates extensive experience in leading Quality Control activities in compliance with ICH and cGMP requirements, managing stability programs, and overseeing analytical results for drug substance and product programs. Proven ability to collaborate across teams and manage relationships with external laboratories while ensuring adherence to regulatory standards.

Highest-signal resume keywords

• Quality Control Testing
• Stability Program Management
• OOS/OOT Investigations
• IND, BLA, CTA CMC Submissions
• CGMP Compliance

ATS Optimization Keywords

Hard Skills

• Quality Management Systems
• Method Validations
• Master Specifications
• Statistical Evaluation
• Analytical Results Review
• Batch Release Processes
• Stability Data Monitoring
• Reference Standard Qualification
• CAPA Management
• Deviation Management

Soft Skills

• Strong Quality Mindset
• Excellent Oral Communication
• Excellent Written Communication
• Team Leadership
• Influencing Skills

Industry Keywords

• Pharmaceutical Industry
• ICH Guidelines
• CGMP
• FDA Inspections
• EMA Inspections
• Clinical Trial Material
• External Laboratories
• CMOs
• Regulatory Environments
• Quality Control Activities