Type:

full-time

Job Description:

We are seeking a Quality Manager to join our team. In this role, you will help support our mission by ensuring high-quality execution of daily responsibilities, maintaining accuracy, and contributing to a collaborative environment focused on patient care and continuous improvement. The Quality Manager is responsible for managing quality assurance and quality control processes and teams at the Albany 503b manufacturing facility. This includes oversight of all quality assurance and all quality control functions. This individual will participate in supporting and independently work through quality processes that reinforce the company's values of customer focus, integrity, collaboration, and innovation while meeting the needs of our stakeholders and regulators. The Quality Manager leads and manages direct reports and ensures their activities occur in accordance with c

GMP, USP 795, USP

797, State Board of Pharmacy regulations, Section 503B of the Federal FD&C Act and company policies and procedures.

The Basics Location:

Albany, OH, Onsite Job Type:

Full Time Schedule:

Mon- Fri Compensation:

The base pay range for this position starts at $110K base plus an annual bonus commensurate with the individual's experience and qualifications.

Benefits:

Eligible

RELOCATION & SPONSORSHIP AVAILABLE FOR QUALIFIED CANDIDATE

How You Will Make an Impact Prepare and/or review/approve controlled documents (e.g. SOP's Batch Records, Specifications, Protocols, Deviation reports, OOS investigations) Review and approve change controls, ensuring adequate justification, impact assessment, and implementation plan. Review and approve executed validation documents ensuring specifications were met. Assist in leading all regulatory inspections of the site, including inspections from FDA and state Boards of Pharmacy. Create annual product reviews. Review and approve all required product label changes. Oversee communication and data exchange with all external laboratories regarding product testing status. Oversee the quality of incoming materials. Oversee the sample reserve program. Support Vendor Management program, including qualification and maintenance of vendors. Ensure direct reports are efficiently and effectively allocated to support customer expectations and the needs of the business. Participate in cross-functional teams in preparation for regulatory inspections, quality agreements, internal and external audits, validation activities, and special projects. Provide quarterly metrics/trends to the General Manager and to the Quality Director. Stay current with applicable laws, federal and pharmacy regulations, and company quality standards. Contribute to the development, management, harmonization, and improvement of quality systems and procedures to ensure compliance. Oversees Sterility Assurance What We Are Looking For Bachelor's Degree 10+ years' experience in biotech/biopharma/medical device/pharma industry 7+ years' working in progressively responsible positions in quality 7+ years' experience managing staff and providing effective leadership to direct reports Have held a quality role that included batch disposition determination Have vast experience with 21CFR Part 11 compliant quality management systems. Experienced in interfacing with regulatory agencies (e.g. FDA) Have prior experience with QMS systems and implementation. Have prior experience in auditing and managing API brokers/manufacturers, contract manufacturing organizations, and or contract testing laboratories. 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