Not Authorized
You are currently not authorized to access this section.
Please contact your Administrator to change your authorization settings.
Please contact your Administrator to change your authorization settings.
Senior Manager, Quality Assurance
San Diego, CA
Job Description
Description
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.
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.
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 an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse. Will need to lift and move boxes of paper and binders weighing up to 20 pounds.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Typical office setting, staff in cubicles, noise level is moderate with consistent printer, telephone ringing and conversation. Employee is in a private office.
Benefits:
- 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
The base pay range for this role in California is $112,000 per year to $154,000 per year.
The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.
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.
Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
8+ years
Email this Job to Yourself or a Friend