Senior Manager, Quality Assurance Operations
Location: On Site. Relocation Required to the Mid-West.
Join a dynamic team driving innovation and quality in the field of life sciences. The company we are partnering with is revolutionizing biotech manufacturing.
What they offer:
- Great compensation.
- Advancement opportunities.
- Resume building position.
All you have to do is relocate for a few years.
We are seeking an experienced Senior Manager, Quality Assurance Operations to lead our quality assurance efforts for drug product manufacturing, packaging, and labeling.
Key Responsibilities:
- Develop and implement comprehensive quality assurance strategies to ensure compliance with regulatory requirements (FDA, EMA) and industry best practices.
- Provide leadership and support to Quality Assurance teams, ensuring adherence to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Oversee incoming material inspection, in-process quality assurance, and final product release.
- Manage and monitor key performance indicators (KPIs) related to quality metrics, providing regular updates to senior management.
- Collaborate with cross-functional teams, including Manufacturing, Supply Chain, Regulatory Affairs, and Quality Control, to resolve quality issues and enhance product lifecycle processes.
- Lead training programs to foster a culture of quality and regulatory compliance within the organization.
Qualifications:
- 6+ years of relevant quality assurance experience in drug product manufacturing, with at least 2 years in a leadership role.
- Strong expertise in FDA and EU regulations related to biologics manufacturing (21 CFR Part 210, 211, 610).
- Bachelor's degree in a life science discipline preferred.
- Experience with labeling in a regulated environment is an asset.
If you are passionate about making a real impact in the life sciences industry, we would love to hear from you.
