Quality Assurance Supervisor (Product Development)

Germer International - Pharmaceutical Recruiting; Madison (WI); On-site; USD 110,000 - 150,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting is seeking a CMDO QA Supervisor to develop, implement, and maintain the Quality System ensuring data integrity for process development, engineering batches, and clinical trials. The role focuses on regulatory compliance and customer inquiries across CDMO projects, with 100% onsite work.

Responsibilities include release of materials and products, procedure maintenance, regulatory dossier support, and audits.

Qualifications

• Bachelor's degree required.
• 5+ years in material release, product development and validation.
• Experience with test method development/validation.
• Experience with investigations approvals, quality agreements, and change controls.
• Preferred: biologics, drug substances, DMFs.

Responsibilities

• Release raw materials, products (development batches, engineering batches, clinical trial batches) and GLP test activities.
• Organize establishment/maintenance of relevant procedures/documents.
• Collaborate with customers and Regulatory Affairs to prepare regulatory dossiers.
• Provide direction on applying quality requirements to CDMO projects.
• Draft and verify CDMO Quality Agreements and ensure compliance (including customer notifications).
• Track and coordinate responses to all customer communications/inquiries.
• Continuous improvement of cGMP Quality Systems for CDMO projects per FDA/ICH/USDA/ISPE.
• Compile and communicate metrics for CDMO projects to management.
• Participate in audits and address audit findings as needed.
• Review/approve CDMO product release and shipping documentation.

Skills

Material release

Product development

Test method validation

Quality agreements

Change controls

Education

Bachelor's Degree

Job description

The CMDO QA Supervisor is responsible for developing, implementing and maintaining the Quality System to support the integrity and compliance of all data generated from process development, engineering batch production, clinical trials, etc. for registration filings before product process validation and related document review. This position is also responsible for development and implementation of a program and related processes for responding to customer inquiries about quality related technical or regulatory compliance for all Company products and services.

This position is 100% onsite.

Responsibilities include:

• Release raw materials, products (process development batches, engineering batches, clinical trial batches) and GLP test activities to support the CDMO business.
• Organize the establishment/maintenance of relevant procedures/documents
• Work in collaboration with customers and the CDMO/Regulatory Affairs departments, assist with the preparation of regulatory dossiers supporting CDMO projects.
• Provide direction and advice on the application of quality requirements to CDMO projects.
• Writes CDMO project related Quality Agreements and verifies the Company is compliant with the approved Quality Agreements (including customer notifications) supporting CDMO projects where necessary.
• Responsible for tracking and coordinating responses to all customer communications/inquiries.
• Responsible for continuous improvement of cGMP Quality Systems to support CDMO projects in compliance with FDA, ICH, USDA, ISPE and other pertinent pharma industry requirements.
• Compiles and communicates metrics associated with CDMO projects to management as required.
• Participates in audits and addresses audit findings where necessary.
• Performs CDMO product release and shipping documentation review/approval.

Job Requirements and Qualifications:

• Education: Bachelor's Degree
• Required: 5+years material release, product development and validation, test method development and validation, approval of investigations, quality agreement and change controls.
• Preferred: experience with biologics, drug substances and DMF's.