Quality Manager 503b cGMP Pharmacuetical

Wedgewood; Albany (OH); On-site; USD 99,000 - 121,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) retirement plan with company contribution

Tuition reimbursement opportunities

Paid time off that increases annually

Job summary

Wedgewood is looking for a Quality Manager based in Albany, OH. In this key role, you will ensure high-quality execution of daily responsibilities while maintaining compliance with regulatory standards.

Your contributions will directly impact our mission of improving the lives of animals through customized medication and compassionate care. The position offers competitive compensation and opportunities for career development.

Qualifications

• 10+ years of experience in biotech/biopharma/medical device/pharma industry.
• 7+ years of experience in progressively responsible quality positions.
• Experience with 21CFR Part 11 compliant quality management systems.

Responsibilities

• Prepare and/or review controlled documents.
• Review and approve change controls.
• Assist in leading regulatory inspections.

Skills

Quality Management

Leadership

Regulatory Compliance

Document Management

Education

Bachelor's Degree

Tools

Quality Management Systems (QMS)

Job description

At Wedgewood Pharmacy, we are dedicated to improving the lives of animals through customized medication and compassionate care. Every role in our organization contributes to helping pets live healthier, happier lives. We are a team driven by purpose, quality, and a shared commitment to animal health.

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.

Basic Information

Location: Albany, OH, Onsite

Job Type: Full Time

Schedule: Mon-Fri

Compensation: $110,000 base plus an annual bonus commensurate with your experience and qualifications

Benefits: Eligible for company benefits

How You Will Make An Impact

• Prepare and/or review/approve controlled documents (e.g., SOPs, 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
• Oversee Sterility Assurance

Qualifications

• Bachelor's Degree
• 10+ years of experience in biotech/biopharma/medical device/pharma industry
• 7+ years of experience in progressively responsible quality positions
• 7+ years of experience managing staff and providing effective leadership to direct reports
• Held a quality role that included batch disposition determination
• Experience with 21CFR Part 11 compliant quality management systems
• Experience interfacing with regulatory agencies (e.g., FDA)
• Experience with QMS systems and implementation
• Experience auditing and managing API brokers/manufacturers, contract manufacturing organizations, and contract testing laboratories
• Sterility experience

What You’ll Love About Wedgewood

• Competitive compensation and benefits
• Opportunities for growth and career development
• A supportive, team‑first culture where your work matters
• The ability to make a real impact on animal health every day
• Medical, dental, vision, and voluntary benefit coverages
• Company‑Paid Life Insurance and disability coverage
• 401(k) retirement plan with generous company contribution
• Paid time off that increases every year
• Tuition reimbursement opportunities
• Strong internal promotion and career development programs

Our Commitment to Inclusion

Wedgewood Pharmacy is an equal opportunity employer. We are committed to building a diverse and inclusive workplace where everyone can thrive.