Quality Manager 503b cGMP Pharmacuetical

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Job summary

Wedgewood Pharmacy in Albany, OH seeks a Quality Manager to lead QA/QC at the 503b manufacturing facility. This onsite role oversees document control, change controls, validations, inspections, and vendor management with a strong emphasis on cGMP compliance and patient safety.

The candidate will manage direct reports, ensure regulatory readiness, and drive continuous improvement across quality systems while aligning with company policies and stakeholder needs.

Qualifications

• Bachelor's Degree required.
• 10+ years in biotech/biopharma/medical device/pharma.
• 7+ years in progressively responsible quality roles.
• 7+ years managing staff and providing leadership.
• Experience with batch disposition determination.
• Experience with 21 CFR Part 11 compliant QMS.
• Experience interfacing with regulatory agencies (FDA).
• Experience with APIs, brokers/manufacturers, CMOs or contract testing labs.
• Sterility experience.

Responsibilities

• Prepare/review/approve controlled documents (SOPs, batch records, specifications, protocols, deviations, OOS).
• Review/approve change controls with justification, impact assessment, and implementation plan.
• Review/approve validation documents ensuring specs are met.
• Support regulatory inspections (FDA and state Boards of Pharmacy).
• Create annual product reviews.
• Review/approve product label changes.
• Oversee communication with external laboratories regarding testing status.
• Oversee quality of incoming materials and sample reserve program.
• Support Vendor Management, including vendor qualification/maintenance.
• Allocate direct reports to meet customer needs and business priorities.
• Participate in cross-functional teams for inspections, quality agreements, audits, validations, projects.
• Provide quarterly metrics/trends to GM and Quality Director.
• Stay current with laws/regulations and quality standards.
• Contribute to development/improvement of quality systems.

Skills

Leadership

Regulatory liaison

Quality systems

FDA inspections

Batch disposition

21 CFR 11

Vendor management

Cross-functional teams

Sterility

Education

Bachelor's Degree

Tools

QMS software

Job description

Quality Manager 503b cGMP Pharmacuetical

Albany, OH

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.

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 cGMP, 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.
• 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
• Strong internal promotion and career development programs

#hp

Pay Range

$110,000 - $110,000 USD

Why We Do What We Do

At Wedgewood Pharmacy, your work has purpose. Every prescription you help prepare, support, or deliver contributes to improving the health and well-being of animals. We are passionate about what we do and proud to build a workplace where people feel supported, included, and valued.

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.