HarbourClubTerherne vacatures

Director – Global Quality Auditing and Supplier Management

Reporting to the Animal Health Global Quality Lead for Compliance and Technical Support, the Director will direct the following aspects of the Supplier Quality Management (SQM) and Animal Health global auditing program.

Responsibilities

• Perform comprehensive and detailed GMP compliance audits of animal health sites, contractors, business partners, and suppliers, requiring approximately 50% worldwide travel.
• Develop and maintain Technical Quality Agreements.
• Design and build Business Continuity Process and Quality Risk Assessment Module in Reliance.
• Implement standard Supplier Qualification process across sites.
• Implement efficiency and productivity improvements in the Supplier Audit Program, including qualifying additional external audit sources/resources.
• Support Supplier Transparency Data Remediation.
• Support new business opportunities through due diligence, pre-contract, and Pre-PAI audits.
• Accept audit assignments, perform audit pre-work, conduct audits, and write audit reports within defined timeframes.
• Maintain an understanding of our company policies, procedures, and guidelines.
• Stay aware of evolving industry and regulatory trends/regulations.
• Obtain and maintain auditor qualification through ongoing training and continuing education programs.
• Coordinate with Site Quality leads on audit refusals and postponements.
• Lead project initiatives to maintain the effectiveness and efficiency of the audit program.
• Negotiate with external firms to attain acceptable corrective actions and independently generate extensive, high-quality GMP documentation.
• Maintain broad-based expertise in cGMPs, company Policies, Procedures, and Guidelines, and regulatory requirements pertinent to the pharmaceutical industry.
• Lead and coordinate with Procurement and impacted Site Quality leads on critical audit findings or audit refusals.
• Generate comprehensive presentations/summary of issues for effective communication to all levels.
• Provide support and administrative functions for the electronic Supplier Tracking and Repository System and assist in data maintenance.
• Lead a team of 8-10 who oversee both internal and external auditing and Animal Health Supplier Quality Management.

Required Qualifications

• Bachelor's degree (Engineering, Science, Business or relevant discipline). Advanced degrees will be considered along with experience.
• Minimum of 10 years of manufacturing, technology, and/or quality experience within an FDA, USDA, and/or EU API, Drug Product, Medical Device, or equivalent environment.
• At least two (2) years of experience in management/leadership positions.
• Experience performing audits of external and internal manufacturers and testing laboratories with a working knowledge of processes to support the manufacturing of APIs and Drug Products.
• Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.
• Ability to travel globally approximately 20-30% of the time.
• Ability to work independently with limited supervision in a virtual-management environment.
• Excellent communication, negotiation, and facilitation skills.
• Proven leadership, managerial, problem-solving, and team-building abilities with sensitivity to diverse cultures.
• Ability to work independently and be decisive in an ambiguous environment.
• Experience and ability to achieve compliance goals through a risk-based approach with a deep understanding of cGMPs and EHS compliance.
• Proven Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost, and shortest lead-time.
• Ability to apply understanding of end-to-end supply chain within external and internal networks and stakeholders to achieve results and contribute to supply chain optimization.

Preferred

• Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.
• Demonstrated ability to lead and drive results/impact for critical business/compliance initiatives.
• Demonstrated ability for process improvement and to create/implement simple, compliant systems in diverse areas.
• Lean Six Sigma belt/demonstrated process improvement experience.

Required Skills

Audit Readiness, Drug Product Manufacturing, FDA Compliance, FDA GMP, FDA Inspections, FDA Regulatory Requirements, Inspection Readiness, Pharmaceutical Development, Pharmaceutical Industry

Job Requirements

Travel: 25% worldwide

Location: U.S. And Puerto Rico Residents Only (with specific exceptions for San Francisco and Los Angeles residents)

Hybrid Work Model: U.S. Hybrid Work Model – three days on-site per week (Monday-Thursday) with Friday remote unless business critical.

Relocation: Domestic/International

Visa Sponsorship: Yes

Shift: 1st – Day

Valid Driving License: Yes

Equal Employment Opportunity

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

Job Posting End Date

11/20/2025

Requisition ID

R372417

#J-18808-Ljbffr