Sr Associate II, IT Quality
Posted on: 18 Jan 2021
Cambridge, MA
Job Description
Job Description
The main responsibility of this person is to provide guidance and review and approve documentation to qualify IT systems and infrastructure components. This person is also responsible for system validation and change control approval of IT systems documentation and change requests. Foundational and executable regulatory expectations for CS. Works with peers locally and globally, when necessary to ensure practices are consistent with requirements and expectations set forth within the governing QMS. May support health authority inspections as a Quality SME within the space.
* Represent ITQ on cross-functional teams in support of SDLC activities for GxP applications, primarily focused on Corporate and Enterprise systems. Drive the deployment of new or modified GxP systems or supporting infrastructure platforms & components through review and approval of life cycle deliverables in compliance with the governing regulations and procedures.
* Perform and manage all supporting quality related activities associated with computerized systems including periodic reviews, exception management (deviation / CAPA), change management, risk management, etc. for assigned systems in alignment with noted KPIs.
* Support all Global Quality initiatives, including Data Integrity, Computerized Systems, Infrastructure, and IT QMS implementation / remediation.
* Perform all assigned and required trainings to maintain 100% compliance.
* Support GxP audit readiness activities
Qualifications
* Minimally BA/BS in Life Sciences, Engineering, or IT with 3-5+ years of relevant industry experience required.
* Hands-on experience supporting implementation of computerized systems within a GxP environment either as a CSV and/or Quality lead.
* Ability to complete tasks independently and with limited oversight.
* Ability to interpret regulatory guidance (GxP) and Biogen policies and procedures into executable and defendable lifecycle documentation
* Executable knowledge of respective regulations governing computer systems and controls such as 21 CFR Part 11, Annex 11, MHRAs data integrity guidance, etc.
* Understanding of risk-based methodologies as it relates to qualification and validation
* Experience supporting health authority inspections
* Good knowledge of IT infrastructure concepts and technologies
Additional Information
As a member of the IT Quality team, the IT Quality Sr Associate helps to define, plan, and perform duties that support major system development life cycle activities.
Biogen
Cambridge, MA
Biogen Inc. discovers, develops, manufactures, and delivers therapies for treating neurological and neurodegenerative diseases worldwide. The company offers TECFIDERA, AVONEX, PLEGRIDY, TYSABRI, and FAMPYRA for the treatment of multiple sclerosis (MS); SPINRAZA for the treatment of spinal muscular atrophy; and FUMADERM for the treatment of plaque psoriasis. It also provides BENEPALI, an etanercept biosimilar referencing ENBREL; FLIXABI, an infliximab biosimilar referencing REMICADE; and IMRALDI, an adalimumab biosimilar referencing HUMIRA. In addition, the company offers RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL), rheumatoid arthritis, two forms of ANCA-associated vasculitis, and pemphigus vulgaris; RITUXAN HYCELA for non-Hodgkin's lymphoma and CLL; GAZYVA to treat CLL and follicular lymphoma; and OCREVUS for the treatment of primary progressive MS and relapsing MS, and other anti-CD20 therapies.
Further, it is involved in developing BIIB098, Opicinumab, and BIIB061 for MS and neuroimmunology; Aducanumab, Elenbecestat, BAN2401, BIIB092, BIIB076, and BIIB080 to treat Alzheimer's disease and dementia; BIIB092 and BIIB054 for treating Parkinson's disease and movement disorders; BIIB067, BIIB078, and BIIB110 to treat neuromuscular disorders; BIIB093, TMS-007, and Natalizumab to treat acute neurology; BIIB104 for treating neurocognitive disorders; BIIB074 and BIIB095 for pain; and Dapirolzumab pegol, BG00011, and BIIB059 for treating other diseases, which are under various stages of development.
The company offers products through its sales force and marketing groups. Biogen Inc. has collaboration agreements with Genentech, Inc., Eisai Co., Ltd., Alkermes Pharma Ireland Limited, Bristol-Myers Squibb Company, Acorda Therapeutics, Inc., AbbVie Inc., C4 Therapeutics, University of Pennsylvania, Applied Genetic Technologies Corporation, and others. The company was founded in 1978 and is headquartered in Cambridge, Massachusetts.
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IndustryBiotechnology
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No. of Employees7,800
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Website
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Jobs Posted445
