Vice President – Quality Assurance

Asahi Kasei

. Establish and maintain the Company’s global pharmaceutical quality system .

Posted 9/21/2026full-timeCary • North Carolina • United StatesLead💰 $320,000 - $350,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in establishing and maintaining pharmaceutical quality systems, overseeing GxP compliance, and leading quality governance across cross-functional teams and external partners. Proven ability to manage quality oversight for commercial products, regulatory inspections, and product quality investigations.

Highest-signal resume keywords

Pharmaceutical Quality SystemsGxP ComplianceBatch DispositionRegulatory InspectionsLeadership in Quality Governance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality OversightChange ControlCAPA ManagementValidation OversightSupplier Quality ManagementAnalytical ReviewDocument ControlQuality Metrics AnalysisInspection ReadinessProduct Quality Review

Soft Skills

LeadershipNegotiationOrganizational SkillsAnalytical SkillsProblem-Solving

Industry Keywords

GMPGDP21 CFR Parts 210 and 211EU RegulationsICH GuidelinesFDA ExpectationsBiotechnologyPharmaceutical IndustryCDMO OversightProduct Modalities

About the role

Key responsibilities & impact

Establish and maintain the Company’s global pharmaceutical quality system
Provide independent Quality oversight across the product portfolio and external GxP network
Lead quality-system governance, management review, document control, training, change control, deviations, investigations, CAPAs, complaints, and product-quality review
Oversee clinical and commercial manufacturing, testing, packaging, labeling, storage, and distribution performed by external partners
Serve as final Quality authority for batch disposition and release within delegated responsibilities
Review and approve batch records, analytical results, deviations, investigations, change controls, CAPAs, specifications, validation documentation, and other product-quality records
Oversee process and analytical changes, technology transfers, validation, new product introductions, acquisitions, and post-approval changes
Qualify, audit, monitor, and requalify CDMOs, laboratories, packagers, distributors, and other GxP suppliers
Establish quality agreements and governance processes with external partners
Monitor quality performance through metrics, management review, trend analysis, and partner governance
Lead inspection readiness and serve as primary Quality representative during regulatory inspections and health-authority interactions
Oversee inspection responses and remediation commitments
Ensure oversight of data integrity, electronic records, computerized systems, and documentation practices
Lead or support significant investigations, product-quality complaints, recalls, market actions, and regulatory notifications
Provide Quality expertise for due diligence, licensing, acquisitions, investigator-initiated studies, and promotional review
Develop and manage the Quality Affairs budget, organizational capabilities, resource plans, and external support
Build and lead a high-performing Quality organization and foster a culture of quality, accountability, compliance, transparency, and continuous improvement

Requirements

What you’ll need

Bachelor’s degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, or a related scientific or engineering discipline
At least 15 years of progressively responsible Quality experience within the pharmaceutical or biotechnology industry, including significant leadership responsibility for commercial products
Experience leading Quality in a fully or substantially outsourced operating model
Experience overseeing CDMOs, contract laboratories, packaging and labeling providers, distributors, and other GxP suppliers
Experience across multiple product modalities and manufacturing platforms
Experience with at least two of oral solid dosage forms, biologics, and oligonucleotide products strongly preferred
Extensive experience with batch disposition, pharmaceutical quality systems, supplier quality, investigations, change control, CAPA, validation oversight, product complaints, and inspection readiness
Strong knowledge of global GMP and GDP requirements, including 21 CFR Parts 210 and 211, relevant EU regulations and GMP guidance, ICH guidelines, and FDA and EMA expectations
Experience interacting directly with regulatory authorities and leading regulatory inspections, responses, remediation activities, and compliance commitments
Ability to make independent, risk-based product-quality and compliance decisions using scientific and regulatory judgment
Experience leading managers and professional staff and establishing Quality governance across cross-functional and external-partner organizations
Strong executive presence and ability to communicate complex quality risks, recommendations, and decisions clearly
Excellent leadership, negotiation, organizational, analytical, and problem-solving skills
Ability to manage multiple priorities in a dynamic environment
Ability to travel 25%, including internationally

Benefits

Comp & perks

Health and insurance benefits
Training and development opportunities
Performance-based bonus eligibility
Competitive compensation package