Quality Manager #37194
Pharmaceutical Albany, OH
Direct Hire Nov 18, 2024
Pharmaceutical
Contemporary Staffing Solutions (CSS) is seeking a Quality Manager to join our client in Albany, OH! This permanent opportunity offers $120,000-$125,000 annually! The Quality Manager is responsible for overseeing quality assurance and quality control operations within a manufacturing environment. This role ensures all processes and activities comply with regulatory requirements and company standards, while leading a dedicated team, managing quality systems, and supporting regulatory inspections.
Key Responsibilities:
Key Responsibilities:
- Manage all quality assurance and quality control activities, ensuring compliance with cGMP, USP standards, and regulatory requirements.
- Review and approve controlled documents, including SOPs, batch records, specifications, deviation reports, and OOS investigations.
- Approve change controls with proper justification, impact assessment, and implementation.
- Oversee validation documentation to ensure product specifications are met.
- Lead regulatory inspections and audits by federal and state agencies.
- Manage vendor qualification and compliance in the vendor management program.
- Communicate effectively with external laboratories regarding product testing.
- Oversee quality checks for incoming materials and manage sample retention programs.
- Lead and develop the quality team, ensuring efficient resource allocation.
- Provide metrics and trend reports to senior leadership, identifying opportunities for improvement.
- Stay updated on regulatory changes and implement necessary updates to maintain compliance.
- Collaborate on projects related to inspections, quality agreements, audits, and validation activities.
- Oversee sterility assurance programs and enhance quality systems.
Qualifications:
- Bachelor’s degree in a scientific or technical discipline.
- 10+ years of experience in biotech, pharmaceutical, or medical device industries.
- 7+ years in progressively responsible quality management roles.
- Strong leadership experience managing quality teams.
- In-depth knowledge of quality management systems (21 CFR Part 11).
- Experience with FDA regulatory audits and agency interfacing.
- Expertise in batch record review, batch disposition determination, and sterility assurance.
- Excellent written, verbal, and interpersonal communication skills.
- Proven ability to excel in a dynamic, fast-paced environment with shifting priorities.
Contemporary Staffing Solutions (CSS) has been a leading provider of contract, temporary, temporary-hire & direct hire solutions. We began as a staffing agency and evolved to a national provider of workforce management solutions with a niche recruitment focus in Accounting & Finance, Call Center & Office, Human Resources, Sales & Marketing, & Information Technology. To learn more about CSS, visit our website: www.ContemporaryStaffing.com.