Quality Manager - CDMO (pharma/biotech experience required)
Location: Greater Milwaukee Area (relocation assistance available)
Pay Range: $125,000 – $135,000 per year
Job Type: Full-time | Typical Hours: Monday–Friday 8 AM – 6 PM | Start Date: ASAP
Responsibilities
- Establish, uphold, and enhance quality and compliance standards
- Monitor internal systems to ensure alignment with regulatory and customer requirements
- Oversee supplier and partner quality programs, including audits, qualifications, etc.
- Manage compliance processes such as deviations, investigations, and product release activities
- Support regulatory submissions and interactions with external agencies and certification bodies
- Lead audit programs, ensuring timely reporting, follow-up, and corrective actions
- Author, evaluate, and approve equipment IQ/OQ protocols
- Supervise QA documentation, including SOPs, batch record reviews, and material approvals
- Promote adherence to cGMP or nutraceutical quality systems
- Respond to customer quality concerns, complaint investigations, and product inquiries
- Collaborate across departments to maintain a culture of continuous improvement
Qualifications
- Bachelor’s degree in life sciences required
- Current experience within pharmaceutical or biotech required
- Minimum 5 years of quality assurance experience required
Job Details
- Seniority Level: Mid-Senior
- Employment Type: Full-time
- Job Function: Quality Assurance
- Industry: Pharmaceutical Manufacturing