Sr. quality consultant

This is a remote position.

QA Consultant – CMO Quality Oversight | Oral Solid Dose

Location: Remote - East Coast

Travel: Occasional - Quarterly

Schedule: Full-Time

Reports To: Pioneer Project Lead | Client Project Lead

Required Industry Experience: Oral Solid Dose Pharmaceutical Manufacturing

Candidate Deck: Pioneer GMP Consulting

About the Opportunity

Pioneer GMP Consulting is seeking an experienced QA Consultant to provide quality oversight of contract manufacturing organizations supporting oral solid dose pharmaceutical products. As a member of the Pioneer team, you’ll join an established group of consultants supporting the client’s external manufacturing quality operations. You’ll report to Pioneer Project Lead Nichol Wilson and collaborate closely with client Quality representatives, CMO personnel, and cross-functional stakeholders. This role extends beyond batch record review. You’ll provide quality oversight across executed batch records, deviations, change controls, CAPAs, supplier quality management, and lot disposition. You’ll apply independent quality judgment to ensure products and supporting quality records meet cGMP requirements, client procedures, regulatory expectations, and applicable quality agreements. Direct oral solid dose manufacturing experience is required.

What You’ll Do

• Provide Quality Assurance oversight of CMOs manufacturing oral solid dose pharmaceutical products
• Review executed electronic and paper batch records for completeness, accuracy, compliance, and readiness for lot disposition
• Evaluate manufacturing documentation for adherence to approved master batch records, procedures, specifications, and cGMP requirements
• Review and assess deviations, investigations, root cause analyses, impact assessments, and proposed corrective and preventive actions
• Review change controls for potential effects on product quality, validated processes, regulatory commitments, and supply continuity
• Support lot disposition by confirming that batch documentation, deviations, testing, and other required quality records are complete and acceptable
• Provide supplier quality oversight and monitor CMO compliance with quality agreements and client expectations
• Identify missing information, documentation discrepancies, recurring quality issues, and potential compliance risks
• Coordinate with CMO Quality, Manufacturing, Technical Operations, Supply Chain, Regulatory, and client stakeholders to resolve issues
• Track quality records and follow up on outstanding actions to support timely closure and product disposition
• Review CAPAs for alignment with identified root causes, appropriate scope, effectiveness, and sustainable risk reduction
• Escalate significant quality events, product risks, compliance concerns, and delays appropriately
• Support quality metrics, issue trending, inspection readiness, and continuous improvement activities as needed
• Maintain clear documentation of quality decisions, review comments, risks, and required follow-up
• Represent Pioneer with professionalism, sound judgment, accountability, and a commitment to client success

Required Qualifications

• Direct Quality Assurance experience supporting oral solid dose pharmaceutical manufacturing
• Demonstrated experience providing quality oversight of CMOs, contract manufacturers, or external manufacturing partners
• Experience reviewing executed batch records for tablet, capsule, or other oral solid dose products
• Experience supporting batch review and lot disposition within a cGMP-regulated pharmaceutical environment
• Hands-on experience reviewing deviations, investigations, root cause analyses, impact assessments, CAPAs, and change controls
• Experience with supplier quality management or external manufacturing quality oversight
• Strong knowledge of cGMP requirements, FDA expectations, good documentation practices, and data-integrity principles
• Understanding of oral solid dose manufacturing processes such as dispensing, granulation, blending, compression, encapsulation, coating, and packaging
• Ability to evaluate complex quality events and make clear, risk-based, and defensible quality decisions
• Strong technical writing and documentation-review skills
• Ability to identify compliance risks, challenge incomplete conclusions, and escalate significant concerns
• Ability to manage multiple quality records and priorities within established timelines
• Ability to work independently while collaborating effectively with Pioneer, client, and CMO stakeholders
• Availability to work approximately 40 hours per week throughout the six-month engagement

What Will Set You Apart

• Extensive QA experience supporting commercial oral solid dose products
• Experience serving as the primary Quality contact for one or more external manufacturing sites
• Experience reviewing complex manufacturing investigations and assessing product-quality impact
• Experience managing supplier performance, quality agreements, quality metrics, and CMO governance activities
• Familiarity with Electronic Batch Record systems and electronic quality management systems
• Experience supporting product release, annual product reviews, regulatory remediation, or inspection readiness
• Experience working across multiple products, CMOs, or global supply partners
• Prior consulting experience within pharmaceutical Quality Assurance
• Ability to integrate quickly into an established team and contribute with minimal ramp-up

About Pioneer GMP Consulting

Pioneer GMP Consulting provides quality, compliance, validation, and operational support to pharmaceutical, biotechnology, and life sciences organizations. Our consultants are members of the Pioneer team and are supported by Pioneer’s leadership and network of industry experts while working directly alongside client teams. Together, we address complex GMP challenges, strengthen quality systems, and support sustainable compliance.

Equal Opportunity Employer

Pioneer GMP Consulting is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected category under applicable law.