Director, Supplier Quality

Job Location:

Dublin, Dublin, Ireland

Job Description:

 

 

Director, Supplier Quality

 

Reports to: Sr. Director, Quality Audit and Supplier Quality

 

Department: Global Operations Quality

 

 

Location: Dublin, Ireland

 

 

 

     

Position Summary & Scope

Develop and manage the one global Supplier Quality process for all Alexion manufacturing and laboratory operations. Own the Supplier approval process. Own all Quality Agreements with suppliers.

Hire, manage, and develop global Supplier Quality team.

Manage the Supplier Corrective Action Request (SCAR) process to effect resolution of root cause problems contributing to unsatisfactory supplier quality performance. Communicate and collaborate closely with suppliers, providing as much information as possible about the non-conformance to ensure that adequate root-cause analysis is performed.

Provide regular updates to management on SCAR performance.

 

Manage the Supplier Management Review process, including preparation of data for the review, summarizing the results and status SCARs initiated with suppliers to drive improvement.

 

Monitor and report on supplier performance indicators and identify improvement opportunities within the supply chain.

 

Work closely with Audit team to ensure that all vendor risks are communicated and included as part of the audit risk management process.

 

Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.

 

 

Principal Responsibilities

  • Develop and deploy global Supplier Quality process for all manufacturing organizations.
  • Own the global supplier approval process and transition existing site based processes to one global process.
  • Ownership of Supplier Corrective Action Report (SCAR) process to drive improvement actions with suppliers.
  • Work with IT organization and Enterprise Quality to develop key workflows and interactions with finance systems.
  • Identify compliance gaps and develop/implement plans to resolve issues and mitigate risk.
  • Assist with developing and maintaining departmental capital and operating expense budget 
  • Establish key objectives aligned with business strategies.
  • Establish and track quality metrics for internal processes, and identify and implement improvement opportunities. 
  • Supervise and provide operational guidance to direct reports. 
  • Support audits and inspections, as appropriate.
  • Performs all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements 

 

 

Qualifications

  • Minimum of 15 years of Quality Management in clinical and commercial manufacturing environment required.
  • Previous Supplier Quality leadership role in the pharmaceutical/biopharmaceutical/medical device industry required.
  • 5 years of people management experience is preferred
  • Previous global Quality System development/deployment experience required
  • Experience managing regulatory inspections required

Education

Bachelor’s degree in Scientific or engineering discipline required

 

Competencies

  • A strong customer focus and ability to prioritize and adapt to business  needs are required
  • Strong leadership, negotiation, collaboration and influence skills in a matrix organization
  • Demonstrated project management skills; experience leading cross-functional teams, and decision making
  • Strong business partner with a focus on delivering results.
  • Knowledge of applicable international GXP regulations and standards
  • Strong ability to analyze systems, data
  • Capable of identifying and mitigating risks
  • Excellent written and verbal communication skills
  • Experience with high performance teams, cross functional projects

 

*LI-JB1

*LI-GO1

 

Dublin, Ireland
 

 

Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.



Apply for this job at https://alexion.contacthr.com/59642724

Contact Information:

Contact: Alexion
Alexion

Posted:

December 31, 2017
UID: 59642724

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