Alexion Pharmaceuticals Specialist, Quality Systems, Document Control in New Haven, Connecticut

Position Summary

A key member of the team responsible for delivery of quality systems oversight for activities to ensure commercial and/or clinical products are manufactured and distributed in accordance with all regulatory and corporate requirements.

This key role must ensure effective interaction and partnering with other departments and locations regarding the operation and compliance of Document Management and GxP Records Archival to cGXP.

Principal Responsibilities:

Areas of responsibilities shall include, but are not limited to:

  • The system management and day to day of GxP Document Coordination in firstDoc.

  • The management of the interface between Documentation Control and Training to ensure updated documents are highlighted to users and routed as appropriate.

  • To co-ordinate the training associated with the use of firstDoc and related systems by stakeholders and to act as point of contact for all firstDoc queries

  • To safeguard and develop Document formats and structured defined within the QMS and to act as process owner for all Document Management related SOPs and to investigate any Document Control or Training related deviations

  • The management and coordination of the e-Room used to communicate key documents to CMO’s as required.

  • To work with external and internal stakeholders on the development of firstDoc and related e-Systems going forward.

  • To coordination the generation of GxP Logbooks

  • Oversee all GxP documents archival in New Haven or approved third parties as required.

  • To support Site License Maintenance and Variation as required and the retention of associated, key Document Masters and Declarations

Profile:

  • A minimum of 5-8 years relevant experience within the pharma industry or a related field.

  • Strong knowledge of cGMP requirements for pharmaceutical manufacturing, packaging and distribution required.

  • Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, IMB/EMA or other authorities of similar standing.

  • Excellent accuracy and attention to detail

  • Good knowledge of relevant computer packages e.g. firstDoc or similar

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

  • High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required.

  • Excellent interpersonal skills and the ability to communicate well, both verbally and written.

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

  • As this role is external facing across APIT function and the wider organization the individual is required to show natural leadership skill of collaboration, leading and directing activities of others towards a defined end goal.

  • Experience of Document Management for manufacturing processes for pharmaceutical products and processes strongly desirable.

Education

  • Third level qualification e.g. B.Sc . in science/pharmacy with a minimum of 5 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.

  • Supervisory experience preferred.

  • Qualified Person eligibility is desirable but not essential.

  • Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).

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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 multinational biopharmaceutical company with approximately 2,500 dedicated employees serving patients in more than 50 countries through the innovation, development, and commercialization of life-changing therapies. As the global leader in complement biology, Alexion developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). In addition, Alexion 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). Our research efforts focus on novel molecules and targets in the complement cascade, and our development efforts focus on our core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders.

Alexion’s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team.

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 www.alexion.com.

Alexion is an Equal Opportunity /Affirmative action employer