Sr. Manager, Quality Assurance – UK

Job title:

Sr. Manager, Quality Assurance – UK

Company

Pacira Pharmaceuticals, Inc.

Job description

Overview:About PaciraPacira 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. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.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:
This role is responsible for providing quality oversight and direction to Pacira’s Contract Manufacturing, Packaging and Testing Vendors, to ensure product is manufactured, tested, released and distributed in compliance with cGMP, applicable state, federal or international regulations as well as internal policies and procedures. Act as primary Quality liaison between Pacira and identified CMO. Responsibilities:Essential Duties & Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.1. Execute batch record review and disposition of finished products for clinical and commercial use, in line with procedures and business timelines for supply continuity.
2. Review and approve CMO investigations for GxP Quality Events.
3. Provide QA guidance to CMO identified GMP deficiencies and resolutions.
4. Support development and maintain quality assurance policies, procedures and metrics.
5. Manage the implementation and day-to-day operation of the Pacira Ireland QMS.
6. Act as the Deputy Management Representative, in accordance with 21CFR Part 4, Regulation of Combination Products, if so designated.
7. Support continuous improvement of GxP systems.
8. Work independently to resolve compliance issues of major complexity.
9. As needed, identify compliance gaps and proactively take steps to remediate.
10. Review and approve CMO GxP documentation (SOPs, MBRs, Validations, Stability Reports)
11. As needed, author or approve new or revise existing internal GxP documents (Quality Events, CC, Stability reports, SOP).
12. Assist in the review of documents and data submitted in or in support of regulatory submissions.
13. Review and approve CMO Annual Product Reviews and support generation of the overall reports for each Product as needed.
14. As needed, conduct GxP audits of vendors and provide support for vendor monitoring program.
15. Other duties as assigned.Supervisory Responsibilities:
This role does not have supervisory responsibilities.Interaction:
The incumbent works closely with appropriate QA contacts at CMOs, within the Pacira UK team and with Pacira US teams, as required, for manufacture, testing and packaging of product which is outsourced by Pacira. Qualifications:Education and Experience:

• 7 years cGMP related experience in biopharmaceutical/pharmaceutical or related industry with direct QA experience in a cGMP environment required

• Bachelor’s degree from an accredited college or university required

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:1. Demonstrated knowledge of Quality Systems and GMPs and their application2. Experience in decision processes, problem solving, root cause analysis and constructive issue resolution3. Leadership, negotiation, conflict management skills4. Ability to work successfully in a fast-paced, rapidly changing environment5. Excellent written, oral, and interpersonal English communication skills6. Strong proficiency in Microsoft Word and Excel applications7. Strong organizational skills with a high level of attention to detail8. Proactively identifies issues and identifies solutions

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. Employee is expected to meet the physical and health requirements for gowning and entry into cleanrooms.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, noise level is moderate with consistent printer, and conversation. The work environment also includes CMO warehouse and manufacturing areas. These areas include eye, ear and foot protection due to various noise levels, chemicals and warehouse operations. Employee is located in open 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

EEO Statement: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.

Expected salary

Location

United Kingdom

Job date

Sun, 23 Mar 2025 02:55:12 GMT

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