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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in product quality leadership, regulatory compliance, and analytical testing within the pharmaceutical industry. Proven ability to manage complex projects, mentor teams, and communicate effectively with cross-functional stakeholders.
Highest-signal resume keywords
Product Quality LeadershipRegulatory ComplianceAnalytical TestingProject ManagementGMP Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality AssuranceProcess DevelopmentAnalytical TechniquesBioconjugate DevelopmentPharmaceutical ManufacturingRegulatory DocumentationNon-Conformance InvestigationsDrug DevelopmentStability ProgramsSpecifications Management
Soft Skills
Leadership SkillsCommunication SkillsMentoringCollaborationFacilitation Skills
Tools & Technologies
GMP SystemsRegulatory Filing Systems
Industry Keywords
PharmaceuticalsCGMPQuality ControlQuality ManagementRegulated EnvironmentCross-Functional TeamsMatrix EnvironmentScientific OversightProduct Development TeamEmerging Scientific Trends
About the role
Key responsibilities & impact- Serve as Product Quality Leader (PQL) and champion for a product team
- Provide technical expertise, strategic leadership, and project leadership to the Product Quality organization
- Collaborate with Product Quality staff and executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance, and other functional areas
- Resolve issues involving process/manufacturing, in-process controls, analytical methods, specifications, comparability, stability, reference standards, importation testing, investigations, change control, regulatory submissions, and inspections
- Implement operationally efficient processes and corporate alignment across international sites
- Support large and small molecule development and commercial lifecycle maintenance
- Lead product quality activities supporting the Product Development Team, including comparability, specifications, stability, and annual product review
- Provide scientific oversight for pivotal and/or commercial products
- Review product data, own GMP documents and regulatory filing sections, execute transactions in relevant GMP systems, and support regulatory audits and responses
- Lead a Product Quality Team, oversee product stability programs, and provide indirect staff management and guidance
- Manage complex long-term PDT deliverables for hybrid modality programs, including specification, comparability, and stability programs; site and method transfers; non-conformance product quality impact statements; regulatory filing sections; and responses to questions
- Evaluate complex processes and product quality data using science- and risk-based approaches
- Communicate complex information to leadership, peers, and regulatory agencies
- Monitor emerging scientific and technical trends and their implications
- Mentor new and existing team members
Requirements
What you’ll need- Doctorate Degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience OR Master's Degree & 7 years of Quality, Operations, Scientific, or Manufacturing experience OR Bachelor's Degree & 9 years of Quality, Operations, Scientific, or Manufacturing experience
- Advanced degree in chemistry, biochemistry, biology, or a related biotechnology sciences field
- Expertise in large and small molecule and bioconjugate development, analytical testing, and industry regulations
- 8+ years of pharmaceutical experience with increasing responsibility in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience
- 6+ years working in a regulated environment (direct GMP)
- 4 years experience managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
- 2+ years experience as a technical expert or product champion
- 1+ years of experience with authoring or review of regulatory filing or similar regulatory documentation
- 1+ years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
- Experience in Project Management in support of product development
- Knowledge of protein and small molecule quality, compliance and regulatory requirements
- Knowledge of analytical techniques used for small molecule and protein product quality control
- Understanding of drug substance and drug product development and manufacturing
- Strong leadership and management skills
- General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals
- Previous experience working on a cross-functional team in a matrix environment
- Excellent written and verbal communication skills, including facilitation and presentation skills
Benefits
Comp & perks- Comprehensive employee benefits package
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible
- Career development opportunities
- Work/life balance support