Director Global Quality Supplier Quality Management

Job Description

Director - Global Quality Auditing and Supplier Management

The Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below 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 our 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

• Bachelors degree (a degree in Engineering Science or Business or relevant discipline). Advanced degrees will be considered along with a combination of 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:

Preferred Skills:

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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