US Regional Project Quality Lead

Job Description
Position Overview - Basic Functions & Responsibilities (including, but not limited to):

• Acts as the QA/QC lead in establishing the quality assurance, quality control and compliance foundation in future project operations. The incumbent represents Quality within the Project Team and ensures guidance and supports provided on all aspects of the project's future operations, including identification, design, development and implementation of the Quality and Compliance processes and systems.

• Designs, and implements appropriate measures to track adherence to established timelines, and project performance standards; The incumbent is responsible for ensuring realization of project goals through post-project execution follow-up mechanisms.

• As a member of the Transfer Quality Team, the incumbent provides Quality strategy guidance and direction, oversight and support to all transfer activities involving the transfers of large molecules from, into, and within the production sites. This includes E2E support, from siting decision through Quality project team management, validation and regulatory approval as well as appropriate, post-execution evaluation.
• With respect to Transfer Quality Compliance Support, the position ensures appropriate support acting as the point of contact for any quality topic including but not limiting:
  
  • Applying AHQM/Quality Standards guidance for US Region transfer projects
  • Applying and communicating/sharing preferred transfer practices
• With respect to Transfer Quality Operational Site Support, the incumbent ensures communication and overview of the progress of the Local Quality activities related to transfers, including, among others:
  
  • Coordination and full support of all local Quality transfer activities.
  • Acting as point of contact for document preparation, and review, and/or questions regarding quality transfer activities.
  • Supports preparation of training programs as required.
  • Provides oversight to the progress of ALL local Quality (QC/QA) transfer activities.
  • Supports the design, and creation of transfer documents, together with transfer's cross functional team.
  • Manages assigned process & Quality site transfer projects in alignment with site's Quality teams and other functions
  • Ensures milestone delivery and prioritization of complex transfer Quality projects, including for Quality Assurance document review, and release processes, Quality Control methods, and stability studies, as required.
  • Ensures milestone delivery and prioritization of process transfer projects connected to site's manufacturing activities.
  • Links closely with Task Force Teams through Global Quality Transfer leadership.
• To be successful, the incumbent has to build and maintain strong relationships with the relevant cross functional teams for transfer, supporting the coordination and aligning individual Quality activities impacting Quality Operations.
• Provides coaching, and upskilling to local cross functional team members on Quality and Compliance aspects of transfers.
• To fulfill the role/position, the incumbent:
  
  • partners closely with Donor or Receiving cross functional teams (across network, and/or within site) to ensure progress of all Quality transfers.
  • partners closely with local quality teams to align on activities and due dates.
  • partners with other global support functions such as Global LMQ Transfer team, Global Supply chain, BTS, R&D, APS, and others as appropriate
  • Supports and ensures collaboration and exchange of preferred cGMP practices across the network.

Location/Travel

• The position is based at the DeSoto, KS site, and may require traveling to other AH sites, up to 30% of the time.

Skills, Education and Experience

• Bachelor's Degree in Chemistry, Pharmacy, Biology or Veterinary or related scientific discipline
• Minimum 7+ years experience in Pharmaceutical Industry with Biological products, including site-based manufacturing or Quality, in a leadership role
• Proven knowledge and understanding of USDA GMP regulations, guidelines and expectations in their application in daily operations.
• Proven analytical and problem-solving skills
• Strong communication and influencing abilities
• Proven ability to manage complex projects
• 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.
• Results-oriented
• Broader understanding of complex (Animal Health) Quality Operations
• A self-motivated, self-sufficient, inclusive leader

#EBRG
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Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
Yes
Hazardous Material(s):
n/a
Job Posting End Date:
05/29/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:05/29/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R294382