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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management and Regulatory Compliance within the pharmaceutical industry, with a strong foundation in chemistry and experience in project management. Capable of developing and implementing quality strategies while effectively communicating complex information across cross-functional teams.
Highest-signal resume keywords
Quality ManagementRegulatory Documentation AuthoringCGMP KnowledgeProject ManagementCross-Functional Team Collaboration
ATS Keywords
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Hard Skills
Quality Strategy DevelopmentRegulatory ComplianceData ManagementComparability AssessmentsNon-Conformance InvestigationsAnalytical TechniquesSynthetic Pharmaceutical DevelopmentMarket Application ReviewRisk AssessmentPharmaceutical Manufacturing
Soft Skills
Excellent Communication SkillsFacilitation SkillsPresentation Skills
Tools & Technologies
GMP SystemsChange Control SystemsData Systems
Industry Keywords
Pharmaceutical SciencesBiopharmaceuticalsRegulated EnvironmentSynthetic ModalitiesU.S. and International Filing Regulations
About the role
Key responsibilities & impact- Provide technical expertise and product leadership to the Product Quality organization
- Work with Product Quality Leaders, International Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on projects, issue resolution, and investigations
- Support synthetic products and provide technical expertise and project support to Product Quality Teams
- Develop, implement, and manage Quality strategy to meet Product Development Team goals
- Own, author, and review GMP and regulatory documents
- Execute transactions in relevant GMP systems, including change control and data systems
- Manage product data, including comparability assessments, annual product reviews, and product quality risk assessments
- Support Product Quality initiatives to ensure overall product health
- Provide cross-functional quality leadership and support PDT deliverables for late-phase and commercial synthetic programs
- Support PQT, APR, specification, comparability, and stability programs; site and method transfers; product quality impact statements for non-conformances; and PQ-owned regulatory filing sections and RTQs
- Evaluate complex process and product quality data using science- and risk-based approaches
- Develop patient-oriented strategies accounting for business needs and provide novel solutions to complex issues
- Communicate complex information to Product Quality leadership, peers, and regulatory agencies
- Apply knowledge of cGMP and international regulatory expectations
Requirements
What you’ll need- Doctorate degree & 2 years of Quality, Operations, Scientific, or Manufacturing experience OR Master’s degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience OR Bachelor’s degree & 6 years of Quality, Operations, Scientific, or Manufacturing experience OR Associate's degree and 10 years of Quality, Operations, Scientific or Manufacturing experience OR High School Diploma/GED and 12 years of Quality, Operations, Scientific or Manufacturing experience
- B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
- 6+ years working in a regulated environment
- 1+ year experience authoring or reviewing market applications, IND, supplements or similar regulatory documentation
- 1+ year experience supporting non-conformance investigations, authoring, reviewing and defending critical product-impacting non-conformances
- Experience in project management in support of pharmaceutical development
- Understanding of synthetic pharmaceutical bulk and drug product development, manufacturing, and analytical techniques
- General knowledge of cGMP and U.S. and international filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals and/or biopharmaceuticals
- Experience working on a cross-functional team in a matrix environment
- Excellent written and verbal communication skills, including facilitation and presentation skills
- A strong foundation in chemistry
- Experience with new synthetic modalities/technologies such as peptides, siRNA, new extended release formulations, and/or combination products is a plus
Benefits
Comp & perks- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
- Work/life balance support