Supplier Quality Auditor

Supplier Quality Auditor

At Minaris Regenerative Medicine our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.

Ensure and promote compliance through external auditing of Minaris Regenerative Medicine’s suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on Minaris Regenerative Medicine’s procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7/Q9/Q10, 21 CFR Part 11, current ISO Medical Device Standards; ISO8573, ISO14644, ISO14698, Data Integrity and Eudralex Volume 4 Guidelines.

The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for Minaris Regenerative Medicine and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites.

Essential Functions and Responsibilities
Develop and maintain a risk-based external auditing program for Minaris Regenerative Medicine harmonized across all sites.

Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all Minaris Regenerative Medicine facilities to ensure complete profile.

Management of ASL to add suppliers and maintain approval status of all suppliers as needed.

Based on ASL status, conduct reviews, and perform audits to qualify each supplier used.

Prepare external audit schedule and conduct audits per the schedule.

Prepare and complete audit reports and communicate audit information to cross functional teams within Minaris Regenerative Medicine and the supplier within a timely manner.

Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures.

Track audit findings for suppliers to completion and ensure timely closure of audit reports.

Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity.

Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers.

Maintain audit files and ensure all files are properly archived.

Author and/or review the External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs and revise for best practices, as needed.

Ensure that Quality Agreements are generated and executed for each Minaris Regenerative Medicine supplier, when applicable.

Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs.

Assist in other Quality System related responsibilities and provide Supplier Quality related support to various departments, as needed.

Qualifications
Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry.

Experience with auditing raw materials/excipients, components, and analytical and micro laboratories.

Proven ability to identify, collaborate, and resolve supplier related compliance issues.

In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs) 21CFR Parts 210/211, Good Laboratory Practices (GLPs) 21CFR Part 58, ICH Q7/Q9/Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) 21CFR Part 1271, and Data Integrity principles.

Working knowledge of ISO Standards: ISO8573, ISO14644, ISO14698 are a plus.

EU and PMDA regulations knowledge and associated guidelines are a plus.

Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences.

Certified Auditor or Lead Auditor credentials required.

Understanding of the manufacture and testing of cellular and gene therapies is desirable.

Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation.

Experience in Quality Assurance, including the ability to identify and resolve compliance issues.

Sound knowledge of aseptic processing and supporting technologies.

Travel required (approx. 50%)

Competencies/Candidate Profile
Exhibit professional mannerisms when dealing with Clients/Suppliers and Minaris Regenerative Medicine personnel

Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint.

Ability to think strategically and tactically (strong detail-oriented).

Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor.

Strong analytical and problem-solving skills.

Flexible and able to adapt to company growth and evolving responsibilities.

Multi-disciplinary knowledge across GxP functional areas.

Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities.

Good verbal, and written communication, and presentation skills.

Demonstrable multitasking, project management, and execution skills.

Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence.

Supervisory Responsibility
No supervisory responsibilities