QA PIP; Greenville, NC)

Pioneer GMP Consulting is a specialized life sciences consultancy focused on delivering high-impact GMP compliance, validation, and quality system solutions to biopharmaceutical clients. We support startups, CDMOs, and global manufacturers across the product lifecycle, from clinical-stage development to commercial readiness.

Job Type: Contract Position

Work Type: 100% Onsite

Duration: Minimum of six months

Pioneer GMP Consulting is seeking an experienced Senior QA Consultant to serve as the onsite Person-in-Plant at a contract manufacturing facility in Greenville, North Carolina.

As a member of the Pioneer team, you’ll represent a confidential pharmaceutical client at its external manufacturing partner. You’ll provide day-to-day quality oversight of manufacturing activities and serve as a trusted liaison among the client, CDMO, and Pioneer teams.

You’ll be responsible for batch release activities and oversight of deviations, CAPAs, change controls, and other GMP quality records. This position requires a senior Quality professional who can establish strong working relationships, apply independent quality judgment, identify and elevate risks, and protect the client’s quality and compliance interests.

• Serve as the onsite Person-in-Plant and primary day-to-day Quality representative at the CDMO
• Provide real-time quality oversight of manufacturing operations and related GMP activities
• Review executed batch records and supporting documentation for completeness, accuracy, and compliance
• Lead or support batch release and lot disposition activities in accordance with approved procedures
• Review deviations, investigations, root cause analyses, impact assessments, and proposed corrective actions
• Review CAPAs for alignment with identified root causes, appropriate scope, and sustainable risk reduction
• Evaluate change controls for potential effects on product quality, validated processes, regulatory commitments, and supply
• Monitor open quality records and follow up with the CDMO to support timely and compliant closure
• Identify documentation gaps, recurring issues, operational risks, and potential compliance concerns
• Participate in manufacturing meetings, quality reviews, and issue-resolution discussions
• Collaborate with CDMO Quality, Manufacturing, Engineering, Technical Operations, Supply Chain, and client stakeholders
• Communicate manufacturing status, quality risks, significant events, and recommended actions to client and Pioneer leadership
• Ensure CDMO activities align with applicable quality agreements, cGMP requirements, client procedures, and regulatory expectations
• Support quality metrics, issue trending, inspection readiness, and continuous improvement activities
• Maintain clear and defensible documentation of quality decisions, risks, and required follow-up
• Represent Pioneer with professionalism, credibility, accountability, and sound quality judgment

• Significant Quality Assurance experience within the pharmaceutical or biotechnology industry
• Demonstrated experience providing quality oversight within a GMP manufacturing environment
• Experience serving as a Person-in-Plant, resident Quality representative, or onsite CMO oversight lead
• Direct experience with executed batch record review, batch release, or lot disposition
• Strong experience reviewing deviations, investigations, CAPAs, and change controls
• Strong knowledge of cGMP requirements, FDA expectations, good documentation practices, and data-integrity principles
• Experience working with CDMOs, external manufacturing partners, or supplier quality organizations
• Ability to evaluate complex manufacturing and quality events and make risk-based, defensible decisions
• Ability to identify significant quality or compliance risks and escalate concerns appropriately
• Strong written and verbal communication skills
• Ability to build productive relationships while maintaining independent Quality oversight
• Ability to work independently in a client-facing consulting environment
• Strong organization, follow-through, and ability to manage multiple priorities
• Ability…