Senior Specialist, QA – Audits and Supplier Management

Job Description

Solvias is an internationally recognized provider of integrated solutions in contract analytical research, development, and manufacturing. The company offers a broad spectrum of services and solutions in the Pharmaceutical, Biotech, Medical Device, Cell & Gene Therapy (CGT), and Cosmetic industries. With headquarters near Basel, Switzerland about 800 highly qualified employees take pride in putting science at the heart of serving customers to bring safer and better products to market faster.

Located at our large molecule headquarters in RTP, North Carolina, the Senior Specialist, QA – Audits and Supplier Management serves as the lead for audit and supplier management Quality Assurance (QA) programs at the site. The position is an onsite role at our new facility for Large Molecule & Advanced Therapy Medicinal Products (ATMP) testing services in a Good Manufacturing Practices (GMP) laboratory environment in Morrisville, NC.

• Serve as lead for the site supplier qualification program, including assessment, qualification, and monitoring of applicable suppliers per internal requirements (i.e., questionnaires, audits, corrective actions/responses, supplier change notifications, supplier complaints, etc.).
• Serve as subject matter expert and lead for internal audit program.
• Serve as QA contact and host for customer audits.
• Coordinates scheduling and preparation activities; performs or supports execution as lead auditor or co-auditor, host, or audit team, follows up on and/or creates audit reports, review and/or resolve and findings or corrective actions in a complete and timely manner.
• Gather and generate audit and supplier-related metrics for Quality Management Review and continuous improvement.
• Mentor and train personnel in auditor and audit readiness requirements and best practices.
• Assist with the development, revision, and review of Quality Agreements.
• Liaison with applicable internal stakeholders to ensure timely and complete performance of audits and resolution of any findings.
• Partner with internal stakeholders to identify, qualify and monitor suppliers per internal requirements.
• Assist with Regulatory Inspections as required.
• Provide timely and effective communication to impacted internal and external stakeholders across different functional areas.
• Work across multiple quality processes within the Quality Management System (QMS) to support daily operations and ensure reliable delivery of data.
• Contribute to continuous improvement of quality and business processes and represent a culture of quality at the site.

Requirements

• Bachelor’s Degree in a relevant scientific or technical discipline (e.g., Chemistry, Biology, Engineering, etc.).
• 5+ years applicable biotechnology/pharmaceutical experience with at least 2 years in QA auditing and supplier management roles.
• Experience within a contract biotechnology or pharmaceutical environment (e.g., CRO, CDMO).
• Strong knowledge of US and EU GMP and data integrity regulations, guidance documents and standards.
• Experience with eQMS platforms and processes. MasterControl preferred.
• Proven experience in writing audit plans, agendas, reports and responses.
• Ability to travel up to 10%

Other Desired Skills/Abilities

• ASQ CQA (American Society for Quality Certified Quality Auditor) or similar certification is a plus.
• Familiarity with an eQMS system, MasterControl preferred.
• Excellent analytical and critical thinking skills.
• Strong attention to detail and organizational abilities.
• Effective communication and interpersonal skills.
• Other duties as assigned.

Reporting Structure

This job reports to:

• Director, Quality and Quality Systems

Note: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

Disclaimer: Solvias North America does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.

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