Great Care, Delivered™ is the promise that we make to our customers.If you have a passion for helping animals, and a love for serving others - we want you to help us deliver on that promise by joining our Quality Team. 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 Federal FD&C Act and company policies and procedures. When and where will you work?
- The Quality Manager position is an onsite position in our Albany, Ohio facility.
What you'll do:
- 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
Who you are:
- Possess excellent written, verbal communication and presentation skills.
- Possess strong interpersonal skills to ensure timelines and priorities are met.
- Your analytical abilities coupled with creative problem-solving skills, is one of your key strengths.
- Working in a dynamic, fast-paced, timeline-driven environment with shifting priorities excites you.
- Hands-on mentality with drive for results.
What you've done:
- Obtained a bachelor's degree in scientific/technical discipline
- 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's in it for you:
- A comprehensive benefits package that includes health, dental, and flexible spending accounts
- 401(k) retirement plan with a generous company contribution to help you save for the future
- Company Paid Life and disability insurance
- Access to voluntary insurance options
- A generous paid time off program that increases every year
- Tuition reimbursement
- Opportunity for growth - We believe in promoting from within and do so through our internal job posting program!
About Us Wedgewood is the nation's largest and most trusted provider of compounded veterinary medications. Its recent merger with Blue Rabbit enables the company to provide veterinarians with next-generation software to streamline patient care and marks a significant evolution in services. Together Blue Rabbit and Wedgewood serve more than 70,000 veterinary professionals and one million animals annually. Wedgewood Pharmacy is an equal opportunity employer.We celebrate diversity and are committed to creating an inclusive environment for all employees.If you require an accommodation due to a special need or disability, please let your recruiter know what accommodations you will need.