Interim QA Director

VTI Life Sciences•High Point, NC

2d•Onsite

About The Position

VTI Life Sciences is seeking an experienced pharmaceutical Quality professional to serve as Interim QA Director for a 6-month assignment supporting an Oral Solid Dose (OSD) pharmaceutical manufacturing facility. The successful candidate may currently be operating at the Senior Manager, Associate Director, or Director level, but must demonstrate the technical knowledge, leadership capability, judgment, and independence necessary to function as the site's senior Quality leader. The Interim QA Director will provide Quality leadership and oversight of pharmaceutical manufacturing operations, maintain the effectiveness of the Pharmaceutical Quality System (PQS), support batch disposition and product release, maintain inspection readiness, and provide senior Quality representation to site leadership, regulatory authorities, and CDMO clients. We offer an opportunity to support our teams of industry subject-matter experts and thought leaders while consulting with leading companies in the Life Sciences industry.

Requirements

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Engineering, Life Sciences, or a related scientific discipline.
Minimum 12 years of progressive pharmaceutical Quality Assurance and GMP experience within FDA-regulated pharmaceutical manufacturing.
Minimum 3–5 years of Quality leadership experience at the Senior Manager, Associate Director, Director, Site Quality Head, or equivalent level.
Demonstrated ability to operate with Director-level responsibility and independent Quality decision-making authority.
Significant experience in Oral Solid Dose (OSD) pharmaceutical manufacturing.
Strong working knowledge of 21 CFR Parts 210 and 211, EU GMP requirements, and applicable ICH guidelines, including ICH Q9 and Q10.
Direct experience with batch record review, batch disposition, and product release.
Demonstrated experience with pharmaceutical quality systems, including deviations, investigations, CAPA, change control, complaints, document control, and Quality Risk Management.
Experience supporting or leading FDA inspections, regulatory inspections, and client/customer audits.
Strong understanding of data integrity and ALCOA+ principles.
Experience with process validation, cleaning validation, equipment qualification, and continued process verification.
Demonstrated ability to lead Quality teams and work effectively with Manufacturing, QC, Engineering, Validation, Regulatory Affairs, Supply Chain, and senior site leadership.

Nice To Haves

15+ years of pharmaceutical industry experience.
Previous experience as a Senior QA Manager, Associate Director of Quality, QA Director, or Site Quality Head.
Previous experience in a CDMO pharmaceutical manufacturing environment.
Experience managing Quality organizations supporting multiple products and clients.
Experience leading FDA inspections and responding to regulatory observations.
Experience improving underperforming Quality Systems and reducing investigation, deviation, CAPA, and change-control backlogs.
Experience transitioning responsibilities to a permanent Site Quality Head or successor.

Responsibilities

Serve as the senior Quality representative and independent Quality voice on the Site Leadership Team.
Provide Quality oversight and risk-based decision-making for pharmaceutical manufacturing operations.
Exercise appropriate Quality authority for batch disposition and product release.
Escalate or halt manufacturing activities when significant product quality, patient safety, or regulatory compliance risks are identified.
Develop and execute site Quality priorities aligned with business objectives and regulatory expectations.
Provide leadership and oversight of the site's Pharmaceutical Quality System (PQS).
Ensure effective management of: Deviations and investigations, CAPA, Change control, Product complaints, Document control, Quality Risk Management, Management review and Quality metrics.
Ensure investigations identify scientifically sound root causes and that CAPAs are appropriate, effective, and completed in a timely manner.
Establish priorities and execute plans for reducing Quality System backlogs.
Provide Quality oversight for OSD manufacturing operations including, as applicable: Granulation, Blending, Compression, Encapsulation, Coating, Tablets and capsules, Granules, Soft gel products.
Provide Quality oversight of critical product and process controls including: Blend and content uniformity, Dissolution, Stability programs, Process validation, Cleaning validation, Equipment qualification, Continued Process Verification (CPV).
Maintain continuous FDA and regulatory inspection readiness.
Provide senior Quality leadership during FDA and other regulatory inspections.
Support responses to regulatory observations and ensure appropriate corrective actions are implemented.
Maintain compliance with 21 CFR Parts 210 and 211, EU GMP, ICH Q9, ICH Q10, and applicable regulatory expectations.
Maintain effective site data integrity governance consistent with ALCOA+ principles.
Serve as a senior Quality interface for pharmaceutical CDMO clients.
Participate in and support client Quality meetings.
Lead or support customer and regulatory audits.
Ensure Quality commitments to clients are appropriately documented, communicated, and completed.
Lead, coach, and develop the site Quality organization.
Assess organizational capability, staffing, technical competencies, and leadership needs.
Establish clear responsibilities, priorities, and accountability.
Promote a proactive Quality culture emphasizing compliance, scientific decision-making, Quality Risk Management, and continuous improvement.
Establish appropriate Quality metrics and tiered management processes.