QA PIP (Greenville, NC)

Pioneer GMP Consulting•Greenville, NC

2d•Onsite

About The Position

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 escalate risks, and protect the client’s quality and compliance interests.

Requirements

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 to work onsite in Greenville, North Carolina, throughout the engagement

Nice To Haves

Ten or more years of pharmaceutical or biotechnology Quality Assurance experience
Prior experience serving as the primary client Quality representative at a CDMO
Experience overseeing commercial manufacturing and product-release activities
Experience managing complex deviations, investigations, CAPAs, and change controls
Experience monitoring CMO performance against quality agreements, quality metrics, and established timelines
Experience supporting regulatory inspections, audit responses, remediation, or inspection readiness
Familiarity with electronic quality management and batch-record systems
Prior consulting experience within a regulated manufacturing environment
Ability to integrate quickly, operate with minimal supervision, and confidently represent client interests
Strong consultative approach and ability to work effectively across client, CDMO, and Pioneer teams

Responsibilities

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