Qualification Validation Manager

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 and 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 Qualification Validation Manager serves as the lead for the equipment qualification, computer system validation and method validation systems for facility operations with the Solvias RTP Quality Assurance (QA) department. The position is an onsite role at our new facility for Large Molecule and Advanced Therapy Medicinal Products (ATMP) testing services in a Good Manufacturing Practices (GMP) laboratory environment in Morrisville, NC.

• Ensures proper qualification of equipment/instruments, validation of computerized systems, and transfer/verification/validation of methods by guaranteeing adherence to the corresponding internal and regulatory requirements.
• Serves as the primary QA contact for validation/qualification, maintenance, document life cycle management, change management and compliance issues.
• Responsible for Site qualification and validation programs.
• Oversee and assist in execution of compliance activities for, including but not limited to:
• Validation oversight of shared systems (e.g., IT infrastructure, LIMS, Chromeleon, etc.)
• Review and approval of method validation/transfer/qualification/verification documents and records (e.g., URS, FRS, FRA, IQ/OQ/PQ, trace matrices, etc.).
• Assignment of equipment/instrument release status
• Develop, track, and manage validation master plans.
• Manages QA qualification and validation personnel.
• Act as qualification and validation subject matter expert for training, projects, audits, and investigations.
• Create, review, and approve Quality Management System documentation and records (e.g., change control, procedures, protocols, reports, CAPA, risk assessments).
• Work closely with internal operational groups and external parties (i.e., customers, vendors) for program deliverables completion.

Requirements

• Minimum of 6 years’ experience in a pharmaceutical/biotechnology environment, with at least 3 years in a qualification/validation role.
• Prior experience managing direct reports and cross functional teams.
• Bachelor’s degree in a technical, scientific, or other relevant discipline.
• Strong knowledge of regulatory requirements (e.g., FDA, EMA, 21 CFR Parts 210/211 and 11, ICH, GMP).
• Working experience within a Quality Management (QMS) and Laboratory Information Management (LIMS) Systems (MasterControl and/or Labware LIMS are a plus).
• Proven experience in writing validation protocols and reports
• Familiarity with different types of laboratory equipment/instruments and methods.

Other Desired Skills/Abilities

• Site or laboratory startup experience is a plus.
• Experience within a contract organization (CRO, CDMO) desired.
• Strong foundations in risk management and continuous improvement.
• Excellent analytical and critical thinking skills.
• Strong attention to detail and organization.
• Effective communication and interpersonal skills.

Reporting Structure

This job typically reports to:

• Director, Quality and Quality Systems (Site Quality Head)

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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