Sr. Manager, Supplier Quality & Process Validation, iovera

Summary:

The Senior Manager, Supplier Quality & Process Engineering is responsible for leading the development, implementation, and oversight of supplier management and manufacturing process quality systems that ensure compliance with regulatory standards (e.g., 21 CFR 820, ISO 13485) and meet business performance goals. This role will manage the qualification and performance of suppliers, execution of supplier audits, implementation of supplier quality agreements, and deployment of robust process validation strategies (IQ/OQ/PQ) across the product lifecycle. The role serves as a cross-functional leader and subject matter expert, bridging Supplier Quality, Procurement, Manufacturing, and Regulatory Affairs to ensure reliable, compliant, and cost-effective sourcing and production operations.

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.

• Lead Supplier Quality Management: Oversee supplier qualification, performance monitoring, risk assessment, and issue resolution to ensure product quality and regulatory compliance.
• Manage Supplier Audits & Agreements: Conduct supplier audits, maintain audit schedules, and ensure robust Supplier Quality Agreements are in place and regularly updated.
• Drive Supplier Categorization & Qualification: Implement and maintain a risk-based supplier classification system and manage initial and ongoing qualification processes.
• Oversee Process Validation Activities: Lead development and execution of validation strategies (IQ/OQ/PQ) for internal and supplier manufacturing processes.
• Drive effective root cause analysis and timely closure of supplier related NCs, SCARs, and when applicable CAPAs related to supplier or process failures.
• Collaborate Cross-Functionally: Partner with Procurement, Manufacturing, R&D, and Quality teams to align supplier and process strategies with business objectives.
• Support Technology Transfers & Change Control: Provide quality and validation leadership for new product launches, tech transfers, and supplier-driven changes.
• Develop and Report KPIs: Establish and monitor key performance indicators related to supplier quality and process validation for management review.
• Demonstrated leadership skills with experience managing teams and collaborating cross-functionally
• Experience leading supplier audits, managing supplier quality agreements, and implementing SCAR/CAPA processes
• Perform other quality-related duties assigned by management, including but not limited to supporting CAPA investigations, data analysis, and continuous improvement initiatives.
• Occasional travel may be required to support product development activities, supplier visits, or audits.

Supervisory Responsibilities:

This person has supervisory responsibilities.

Interaction:

The incumbent works closely with various departments (e.g., QC, QA, Operations, Regulatory and within R&D).

Education and Experience:

• BS Degree or higher in science field required (e.g., Industrial Engineering, computer system, Life Sciences).
• Minimum 7 years' experience in medical device manufacturing, or validation or supplier relations.

Knowledge, Skills, and Abilities:

• A practical and working knowledge of ISO 13485, 21 CFR 820 (preferred)
• Experience with Design Controls
• Statistical knowledge and understanding of measurement uncertainty (preferred)
• Detail oriented, well organized and have excellent communication skills
• Able to accomplish objectives with minimal supervision

Physical Demands:

The physical demands described here are representative of those that must me 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.

Duties of this job may involve standing and/or walking, but for most part sitting for extended periods of time. Duties also involve daily keyboard data entry. 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 with a laboratory, offices, warehouse, and cubicles. Noise level is moderate with consistent printer, telephone ringing and conversation.

• 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 is $120,000 annually to $165,000 annually 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.