Associate Director, Global GxP Audit Lead-Quality

Company: Alexion Pharma Spain S.L.
Location: New Haven
Posted on: September 13, 2020

Job Description:

Associate Director, Global GxP Audit Lead-Quality Attention: If you are a current Alexion employee, please apply via

Alexion’s internal Life & Career portal . Note that you will need to be connected to the VPN if you are applying away from the office.

Alexion does not contact candidates via instant messaging or chat tools. At no time will we ask candidates for fees associated with obtaining software, nor do we provide employees with a cashier’s check to purchase new equipment. If you are contacted in this manner, please be aware that it is fraudulent, and please do not provide any information or money to these individuals. Applicants should only apply through this Alexion website. Any fraudulent activity should be reported to GSOC@alexion.com

Share this job This position can be located in an Alexion office in the following cities: Boston, MA; New Haven, CT; San Francisco, CA; or Blue Bell, PA

Position Summary

Responsible for the scheduling, coordination and completion of Alexion GxP internal, external, and supplier audits and compliance in accordance with international GxP requirements and Alexion Quality standards.

Ownership of the Internal, External, and Supplier GxP audit programs.

Management of all activities related to the successful operation of the GxP audit programs, including development, implementation and maintenance of Quality System procedures and documentation.

Lead or participate in audits of vendors to evaluate processes, systems and procedures for compliance to GxP requirements and Alexion Quality standards.

Define audit schedules, assign responsibilities to audit team members, and provides audit preparation materials, instructions and training as appropriate.

Assembles audit teams with appropriate skills and experience and ensures audits of internal departments and external vendors are performed according to approved audit schedule.

Coordinates completion of internal audits of Alexion to assess compliance to international GxP requirements and Alexion Quality standards. May conduct audits to assess inspection readiness of Alexion and vendors.

Coordinates and reviews audits of Alexion GxP suppliers to assess compliance to international GxP requirements and Alexion Quality standards

Ensures timely issuance of audit reports and follow-up on responses and corrective actions. Tracks completion of activities from scheduling through to audit closure.

Coordinates completion of for cause audits of business partners to assess regulatory risk and propose recommendations to senior management.

May create or revise standard operating procedures relating to audit program, and other related documentation.

Drive QA KPI/Metrics performance and contribute to the Quality Management review process.

Up to 30% travel required

Qualifications

7-10 years’ experience in Quality Assurance role, of which at least 4 years must be in an Audit or Compliance related role

Experience auditing in a regulated environment is essential

Demonstrable project management skills; experience working in cross-functional teams.

Strong Buisness Partner with a focus on collaboration and delivering results.

Thorough knowledge of international GxP regulations and standards; expert knowledge of GVP, government regulations and guidelines (EMA, FDA, PMDA) desirable

Education

Bachelor's Degree in physical /life science or pharmacy; Advanced degree preferable

*LI-MB1

Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) as well as the first and only approved complement inhibitor to treat atypical hemolytic uremic syndrome (aHUS), anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing several mid-to-late-stage therapies, including a second complement inhibitor, a copper-binding agent for Wilson disease and an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases as well as several early-stage therapies, including one for light chain (AL) amyloidosis and a second anti-FcRn therapy. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes’ list of the World’s Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts’ Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.

As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.

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Keywords: Alexion Pharma Spain S.L., New Haven , Associate Director, Global GxP Audit Lead-Quality, Other , New Haven, Connecticut