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Quality Assurance Manager, External Quality

Alexion Pharmaceuticals

This is a Full-time position in Wilmington, DE posted December 29, 2021.

Some opportunities happen only once in a lifetime – like a job where you have the chance to change lives.

At Alexion, people living with rare and devastating diseases are our Guiding Star.

We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives.

We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

*This position can be based from any of the following AstraZeneca/ Alexion locations; Wilmington, DE, Boston, MA, New Haven, CT, and may require up to 25% travel.

*Boston, MA and New Haven, CT are preferred locations.

Position Summary

The Manager for external quality provides leadership for the contract manufacturing quality organization for clinical product.

This includes managing day-to-day activities to ensure on-time, RFT (right first time) oversight, and release of clinical DS, DP & FP.

Principal Responsibilities

  • Manages and directs the team to execute quality oversight of contract manufacturing organizations, including systems and processes pertaining to risk management, change implementation, deviation/investigation review, CAPA, and batch release.
  • Serve as Quality Assurance support for Drug Substance, Drug Product, and Finished products Biologics.
  • Ensures the delivery of product to the required specification for Alexion.
  • Provides oversight of GMP systems completed by CMOs and External Supply Chain function related to Drug Substance, Drug Product, and Finished Product.
  • Works directly with contract QP facilities to ensure seamless communication of release requirements, documentation, and timelines as per current QAG.
  • Manages the team that dispositions product for clinical product at CMO (contract manufacturing organizations) in alignment with the clinical supply schedule.
  • Manages the relationship between CMO Quality and Alexion Quality.
  • Provides oversight to continuous quality system improvements and supports implementing improvements at CMOs in compliance, Preventive Maintenance, Deviation Management, and Change Control Programs as they impact Alexion.
  • Negotiates and oversees Quality Agreements between CMO and Alexion.
  • Manages and oversees the technical transfer and New product introduction of all products within scope for the team.
  • Manages the tired communication process and leads the whiteboard tracker (Tier I/ II) to ensure day-to-day activities are managed in New Haven, release activities are communicated and scheduled within the team.
  • Quality point of contact for External Quality team for Global Clinical supply team.

Qualifications

  • Bachelors degree in science, pharmacy, engineering, or equivalent required; advanced degree a plus.
  • Experience with working with CMOs and release of clinical material.
  • Eight or more years of experience in the pharmaceutical industry required with three or more years in a leadership role

*LI-MB1

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines.

Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. 

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer.

We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness.

The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, parental status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.

Alexion provides reasonable accommodations to meet the needs of candidates and employees. 

As a leading employer in our industry, Alexion offers 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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