The Quality Manager is responsible for managing and advancing quality assurance and quality control processes and teams at the San Jose 503b manufacturing facility. This includes oversight of all quality assurance and all quality control functions. This individual will be responsible for maintaining high quality standards and ensuring regulatory compliance. The Quality Manager oversees 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 will you work?

• The hours for this position are Monday - Friday, . Flexibility to support business needs

What you'll do:

• Lead internal audits and regulatory inspections, including inspections from FDA and state boards of pharmacy. Responsible for drafting timely, accurate responses and evidentiary documentation.
• Enforce and strengthen quality management systems and procedures, including quality risk assessment and risk mitigation
• Prepare and/or review/approve controlled documents (e.g. SOP's Batch Records, Specifications, Protocols, etc.)
• Review and approve change controls ensuring adequate justification, impact assessment and implementation plan
• Review and approve executed validation documents ensuring specifications were met
• Lead cross-functional teams to resolve quality issues (e.g. complaints, OOSes, NCRs, RCAs)
• Responsible for the quality of incoming materials and manufacturing process controls, ensuring cGMP compliance.
• Provide site level support and approval as it relates to enterprise quality vendor management program
• Ensure direct reports are effectively allocated to ensure alignment with organizational goals and quality/regulatory standards.
• Monitor quality metrics and trends, including monitoring CAPA resolution
• Stay current with applicable laws, federal and pharmacy regulations, and company quality standards.

Who you are:

• Have a strong understanding of cGMP as it pertains to a sterile injectable drug manufacturing facility.
• Possess excellent written, verbal communication, and presentation skills.
• Your analytical abilities, coupled with creative problem-solving skills is one of your key strengths.
• The ability to work in a dynamic, fast-paced, and timeline-driven environment with shifting priorities excites you.
• Have experience with 21CFR Part 11 compliant quality management systems.
• First-hand experience interfacing with regulatory agencies (e.g. FDA)
• Ability/willingness to travel up to 10%.

What you've done:

• Obtained a bachelor's degree in a scientific/technical discipline.
• 5+ years' experience in the biotech/biopharma/medical device/pharma industry.
• 5+ years' working in progressively responsible positions in quality.
• 5+ years' experience managing staff and providing effective leadership to direct reports.
• Have been in a Quality role that included batch disposition determination.

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 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.

Equal Opportunity Employer
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