Senior Manager, Quality Assurance
Description
Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients.
Why work with us?
Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking – a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together.
- Lead and manage the Quality Assurance Batch Release group to ensure all batches (commercial and clinical) are reviewed in accordance with cGMPs and dispositioned appropriately.
- Lead and manage the internal/external audit department to ensure audits are conducted in accordance with cGMPs and internal standards. As needed, conduct external audits. Approve executed external/internal audits. Manage the Approved Supplier List.
- Proactively participate and direct investigations. Provide QA input to ensure investigations are thorough, root cause identified and appropriate CAPAs are implemented.
- Develop department plans, strategies and provide input for budgets that are aligned with company goals and objectives. Identify areas of GMP non-compliance and proactively work to remediate.
- Provide QA leadership in all matters relating to product quality, disposition and release of materials and finished products.
- Facilitate/participate or host Regulatory inspections.
- Assist Regulatory Affairs in preparation of filings and submissions.
- Review and approve Master Batch Records and Standard Operating Procedures (SOPs) ensuring internal and external standards are met.
- Review and approve Validation Protocols/Reports ensuring internal and external standards are met.
- Provide solutions to GMP problems that are both complaint and in alignment with Pacira standards and goals.
- Other duties as assigned by Quality management.
- 8 years of relevant pharmaceutical experience in a Quality Assurance position required. Minimum of 3 years of supervisory experience required.
- B.S. degree in a scientific discipline from an accredited college or university preferred.
- Experience in aseptic processing preferred.
- Solid understanding of GMPs and their application required, MasterControl QMS experience a plus.
- Ability to conceptualize, analyze, plan, organize and lead cross-functional projects
- The ability and skills to manage and direct a team of employees performing complex technical responsibilities
- Strong oral, written and interpersonal English communication skills
- Strong communication, leadership, presentation, interpersonal, and organizational skills
- Proficiency in Microsoft Excel, SharePoint, Word, Power Point and Adobe Acrobat applications
- Demonstrated strong leadership and managerial skills
- Medical, Prescription, Dental, Vision Coverage
- Flexible Spending Account & Health Savings Account with Company match
- Employee Assistance Program
- Mental Health Resources
- Disability Coverage
- Life insurance
- Critical Illness and Accident Insurance
- Legal and Identity Theft Protection
- Pet Insurance
- Fertility and Maternity Assistance
- 401(k) with company match
- Flexible Time Off (FTO) and 11 paid holidays
- Paid Parental Leave
EEO Statement:
Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law.
At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer:
Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.