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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates strong leadership in third-party quality management and compliance within the pharmaceutical industry, with a focus on strategic operational initiatives and talent development. Possesses advanced knowledge of regulatory requirements, quality risk management, and continuous improvement methodologies.
Highest-signal resume keywords
Pharmaceutical Industry ExperienceQuality Risk ManagementRegulatory Compliance KnowledgeLeadership and Strategy DeploymentCross-Functional Collaboration
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 ManagementRegulatory Agency RequirementsGMP ApplicationClinical Development ProcessProcess ImprovementContinuous Improvement MethodologiesDrug Development KnowledgeTechnical Expertise in R&DQuality Performance MetricsAuditing and Mitigation Activities
Soft Skills
Strong Communication SkillsPeople ManagementTalent DevelopmentInfluencing SkillsNegotiation Skills
Industry Keywords
Biologic Drug SubstanceSterile and Non-Sterile Bulk Drug ProductMedical DevicesCombination ProductsThird-Party ContractorsVendor ManagementQuality PerformanceAudit ObservationsCompliance GapsOperational Leadership
About the role
Key responsibilities & impact- Provide strategic, scientific, and operational leadership to teams responsible for third-party quality management and due diligence
- Lead strategic operational initiatives and build organizational talent
- Oversee third-party contractors and vendors providing biologic drug substance, sterile and non-sterile bulk drug product, medical devices, and combination products
- Define and drive quality performance and compliance robustness across a designated vendor base
- Support development and execution of the global third-party quality management vision
- Execute daily operational third-party quality management support for complex outsourced biologics and drug product activities
- Develop and drive quality strategies and improvement initiatives aligned with business objectives
- Support Global Auditing with audits and mitigation activities for audit observations
- Interact cross-functionally and cross-divisionally with senior management on quality/regulatory matters and special projects
- Interact externally with inspectors and industry colleagues
- Drive resolution of complex contractor/vendor business practice, quality, and compliance issues
- Identify trends and potential compliance gaps and lead resolution of significant quality and efficiency issues
- Coach, mentor, and develop team members and colleagues
- Supervise approximately nine quality professionals
Requirements
What you’ll need- Bachelor's degree in engineering, Biology, Chemistry, or related field
- Minimum of 10+ years of relevant experience in the pharmaceutical industry, or an advanced degree with 8+ years of relevant experience
- Experience interacting with regulatory officials and external auditing parties
- Advanced knowledge of the clinical development process and associated stakeholder organizations
- Technical and quality expertise in pharmaceutical R&D
- Strong scientific/technical expertise in R&D activities
- Strong compliance knowledge and understanding of regulatory agency requirements and GMP application in an R&D environment
- Deep drug development knowledge
- Knowledge of continuous improvement methodologies
- Leadership and strategy deployment experience in a pharmaceutical environment
- Track record of delivering process improvement benefits in a pharmaceutical environment
- Experience in quality risk management in the pharmaceutical industry
- Strong cross-functional collaboration, influencing, and negotiation skills
- Strong oral and written communication skills
- People management and talent development experience
- No visa sponsorship available
- 25% travel requirement
- Regular employee status
Benefits
Comp & perks- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Relocation: Domestic