US Regional Project Quality Lead

Job Description

Join our Leadership Team as the US Regional Project Quality Lead!  The Quality Lead builds and maintains strong relationships with the relevant cross functional teams for capital projects, supporting the coordination and alignment of individual Quality activities impacting Quality Operations.  The Lead is responsible for the quality aspects of equipment and facility commissioning and qualification, and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations, employing Quality Risk Management principles.

The Lead will manage our Quality teams through end-to end support, from siting decision through Quality project team management, validation and regulatory approval as well as appropriate, post-execution evaluation.

Responsibilities:

• Acts as the QA/QC lead in establishing the quality assurance, quality control and compliance foundation in future project operations. Represents Quality within the project team and ensures guidance and support are provided in all aspects of the project’s future operations, including identification, design, development and implementation of the Quality and Compliance processes and systems.
• Provides coaching and upskilling to local cross functional team members on Quality and Compliance aspects of commissioning and qualification activities.
• Coordination, oversight and full support of all local qualification and validation activities.
• Point of contact for document preparation, and review, and/or questions regarding qualification activities.
• Supports preparation of training programs as required.
• Supports the strategy and design of qualification/validation methodologies, together with the project’s cross functional team.
• Ensures milestone delivery and prioritization of key phases of facility and equipment qualification and validation.
• Designs and implements appropriate measures to track adherence to established timelines, and project performance standards; ensuring realization of project goals through post-project execution follow-up mechanisms. 

Location/Travel :

• The position is based at the DeSoto, KS site, and may require traveling to other AH sites, up to 25% of the time.

Minimum Qualifications:

• Bachelor’s degree in Chemistry, Pharmacy, Biology or Veterinary or related scientific discipline
• Minimum 7+ years’ experience in a leadership role within the Pharmaceutical Industry with Large Molecule/ biologics manufacturing, including site-based manufacturing or Quality
• Proven knowledge and understanding of USDA GMP regulations, guidelines and expectations in their application in daily operations.
• Broader understanding of complex (Animal Health) Quality Operations
• Proven analytical and problem-solving skills
• Strong communication and influencing abilities
• Proven ability to manage complex capital projects including commissioning, qualification and validation
• Strong ability to initiate and drive change within complex organizations
• Learning ability: autodidactive, actively learning new concepts, applying in practice and training others
• Task-oriented leadership connects to strategy, leads complex multidisciplinary (global) projects and programs and has the ability to drive project sponsorship and gain support and resources.
• Relationship building to peers (including global functions) and senior management.
• Focus on results: drives results based on strategy and customer needs.
• Self-reflection: is actively looking for feedback and translates this to personal development actions.
• A self-motivated, self-sufficient, inclusive leader

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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, prote