Sr Manager External Quality

Alexion Pharmaceuticals, Inc.
New Haven
Oct 05, 2017
Oct 14, 2017
Employer Type
Direct Employer
Employment Type
Full Time
Senior Manager, External Quality

Position Summary

Responsible for providing quality input and oversight for successful life cycle development and commercialization of biologic and non-biologic drugs at external manufacturing partners globally and ensuring that the operational business is in compliance with cGMP, the Quality Agreement, regulatory requirements and Alexion's Quality Management System. The Senior Manager, External Quality, will act as the lead quality point of contact for assigned programs.

Principal Responsibilities

* Acts as the Lead Point of Contact for all quality related activities at assigned CMOs. Is the voice of Alexion for assigned CMOs.

* Negotiates contracts and Quality Agreements with assigned CMOs which clearly define cGMP roles and responsibilities.

* Ensures Quality Agreement responsibilities are met by partner and Alexion.

* Ensure that all aspects of the handling, manufacturing and distribution of biologic and non-biologic drugs are in compliance with the Alexion's quality management system, the effective Quality Agreement and meets relevant cGMP regulatory requirements.

* Ensure that all GMP documentation, including change requests and deviations, either from the external manufacturing partner or from Alexion, are managed in a timely manner according to the Quality Agreement and Alexion SOPs.

* Perform Alexion batch release of products manufactured at external partners.

* Perform on-site visits and quality business reviews at external manufacturing partners to assess compliance with cGMPs and Alexion requirements.

* Act as quality lead for technical transfer activities at external manufacturing partners.

* Responsible for performance of quality risk assessments and driving risk reduction improvement plans and remediation where necessary.

* Drive quality compliance and performance metrics with external manufacturing partners. Report metrics on routine basis.

* Participate in Health Authority inspections and Alexion inspections of external manufacturing partners to ensure successful inspection outcomes and maintain a constant state of inspection readiness at these sites.


* A minimum of 10 years relevant experience within the pharmaceutical industry.

* Experience with management of contract manufacturing organizations desirable.

* Experience of manufacturing processes for biopharmaceutical products required.

* Experience in new product introduction and technical transfer of biologic and non-biologic drugs

* In depth knowledge of current regulatory requirements for cGMP operations.

* Direct experience of GMP audit management within the pharmaceutical industry is essential, and will include exposure to FDA, EMA or other authorities of similar standing.

* Demonstrated success in quality management and the resolution of technical challenges require significant appropriate experience

* Experience negotiating contracts and/or Quality Agreements with partners required.

* Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.

* High level technical skills including quality risk management, auditing and pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required.

* Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.

* The individual in this position is expected to represent Alexion interests, objectives and policies in a responsible and professional manner.

* Ability to travel 25 - 50% of the time.


* BS in science, engineering, or equivalent required. Advanced degree a plus.

* Minimum of 10 years of directly related experience in the pharmaceutical industry, with at least 3 years in a quality role. Biopharmaceutical industry experiences required.

* Minimum 5 years of experience in a leadership role.

* Project management experience preferred.

* LI-JB1

* LI-DD1

New Haven, CT, United States

No Selection

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.

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. To learn more about Alexion, please visit or download our App for iPhones and Blackberries.

Alexion is an Equal Opportunity /Affirmative action employer