Senior Manager, Quality Assurance

About Pacira
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.      Each of our 3 marketed products, both in pharmaceutical and medical device, represent cutting edge technologies for pain management.    We have 700+ employees and have averaged double digit growth year over year for the past 5 years, with $500M in revenue. We are small enough for you to make your mark, and big enough for you to learn and grow!     We have facilities in New Jersey, California and Florida. Our San Diego, CA campus is a world class manufacturing and R&D facility. We are rapidly growing and have opportunities across all of our sites and functional areas.

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.      Summary:  The purpose of this position is to provide organizational management and leadership to the Quality Assurance Disposition and audit functions and ensure the cGMP compliance of all operational areas.    Essential Duties & Responsibilities:  

• 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.

  Supervisory Responsibilities:   This position has supervisory responsibilities.    Interaction:   The incumbent works closely with Manufacturing Operations, Engineering, Facilities, Quality Control, Microbiology, Process Development, Supply Operations, Analytical R&D, Clinical and Regulatory Affairs.  In addition, the incumbent interacts outside the company with partners, suppliers, regulatory agencies, and professional groups.    Education and Experience:  

• 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.

  Qualifications:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.        Knowledge, Skills, and Abilities:  

• 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

     Physical Demands:  The physical demands described here are representative of those that must be met by