Metric Bio is partnered with a leading CDMO searching for a Senior QA Compliance Specialist for their full GMP CMO facility in Wisconsin, specializing in GMP intermediates, APIs, and excipients.
This on-site, permanent role offers a competitive compensation package and an innovative work environment.
Role Overview: The Senior QA Compliance Specialist ensures adherence to cGMP compliance and regulatory standards, promoting quality benchmarks aligned with US FDA and international regulations.
Reporting Structure:
- Reports to the Director of Quality and Regulatory Affairs.
Key Responsibilities:
- Develop and maintain high-quality standards.
- Monitor and enforce quality assurance policies and procedures.
- Conduct audits to enhance product quality and compliance.
- Manage QA activities with internal and external partners, including audits and quality agreements.
- Ensure compliance with regulatory submissions (DMF/VMF).
- Oversee QA for suppliers and co-development partners.
- Conduct internal and external audits and regulatory inspections.
- Collaborate on Food & Flavor and Nutraceutical quality activities.
- Author SOPs and manage documentation, including batch records.
- Lead compliance training and support purchasing evaluations.
- Engage with customers regarding products and specifications.
- Manage internal and external compliance audits.
Qualifications:
- Bachelor’s Degree in life sciences or a related field.
- 3+ years of QA experience in a biotech/pharma organization adhering to GMP standards.
- Strong passion for pharma/CMO management and product quality.
Other Requirements:
- Professional demeanor with strong communication and organizational skills.
- Ability to work independently and as part of a team.
Prerequisites:
- Minimum B.S. in Science or related field, with direct QA experience highly desirable.
Salary range
- Competitive - depending on experience $70K - $130k.