Manager, Investigations

Recruiter
Alexion Pharmaceuticals, Inc.
Location
New Haven
Salary
Competitive
Posted
Oct 06, 2017
Closes
Nov 02, 2017
Industry
Education
Employer Type
Direct Employer
Employment Type
Permanent
Hours
Full Time
Manager, Investigations

Position Summary & Scope

The Manager, Investigations has a global focus within Global Operations, and supports the implementation and continuous improvement of the QMS.

The Manager, Investigations will assist in the design, implementation and maintenance of the following processes: Quality Notification to Senior Management, regulatory reporting (BPDR, MDR, EU Defective Product), CAPA Review Board and product recall for Global Operations.

Principal Responsibilities

* Implement and maintain of Divisional/ global procedures/ processes associated with but not limited to CAPA, deviation, regulatory reporting (BPDR, MDR, EU defective Product reporting), product recall, Quality Notifications to Sr. Management and quality investigations

* Establish and drive Change Control Review Boards for global process/ procedural changes as required

* Ensure timely closure of quality records in compliance with established procedures

* Lead periodic reviews of Quality System KPIs and other metrics to identify opportunities for improvement, and mitigate compliance risks

* In collaboration with the Training group, develop and deliver training programs for Global Operations for the above activities

* Support the management of a divisional CAPA Review Board which systematically assesses open CAPAs for timeliness, global applicability, and consistency while ensuring alignment with Enterprise and regulatory requirements

* Support audits and inspections, as appropriate

* Other duties as assigned

Qualifications

* Minimum of 7 years of experience in pharmaceuticals/ biopharmaceuticals or related industry with a concentration in Quality Operations/ Systems, investigation techniques, root cause analysis and risk assessment

* Previous working experience in a biopharmaceutical/ pharmaceutical or medical device manufacturing environment required

* In depth knowledge of global GxP regulations

* Global level experience is preferred

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

* Demonstrated project management skills, experience leading and participating on cross-functional teams, problem solving and decision making

* Strong business partner with a focus on collaborating and delivering results.

* Strong leadership, negotiation, collaboration and influence skills in a matrix organization

* Knowledge of applicable international GXP regulations and standards

* Strong ability to analyze systems, data

* Extensive knowledge of investigation techniques and tools

* Extensive knowledge of risk assessment strategies and tools

* Capable of identifying and mitigating risks

* Excellent written and verbal communication skills

* Experience with high performance teams, cross functional projects

* LI-JB1

* LI-DD1

New Haven, CT, United States

New Haven, CT

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

SDL2017