at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Our Global Quality Assurance group is looking for an Assoc Director/Director to lead our Quality eSystems.
The Assoc Director/Director, Global Quality eSystems ensures that the infrastructure and GxP software applications are maintained in a regulatory compliant state. This includes compliance with the FDA's 21 CFR Part 11 in the US and the equivalent international regulations and guidelines e.g. EU Annex 11.
The Director provides quality leadership and guidance to the IT organization through strong collaboration and partnership to ensure that a compliant, efficient, and scalable IT systems and processes enable the execution of organizational initiatives and promote inspection readiness.
Essential Functions of the Job (Key responsibilities)
Provide global leadership and direction of contemporary practices and interpretation of international regulations as applicable computer system validation in the life science industry.
Assure alignment on the relevant global processes and practices, between global and local team. Promote and drive "one global process" philosophy.
Assess all global software systems to determine if the use requires validation as per 21CFR part 11 or Annex 11 or equivalent international regulations. Maintain a list of all global systems that require regulatory compliance.
Champion Data Integrity Quality and Compliance initiatives.
Oversee and act as the lead auditor as applicable to conduct audits of software vendors.
Monitor and maintain IT vendor qualification status and risk reduction program.
Oversee IT Computer Systems Validation projects, ensuring compliance with Incyte global computer systems validation policies and procedures, providing guidance to IT CSV staff as needed, reviewing and approving IT validation project deliverables (e.g. Validation Plan, User and Regulatory Requirements, Validation Summary Report, Change Control documents).
Create and drive implementation and maintenance of global computer system validation quality related policies and procedures to ensure that they remain up to date and aligned with current best practice for the discipline.
Provide Quality review and approval of Deviations, CAPAs, Change Controls and other quality events.
Provide solutions to meet IT Quality systems' needs, and also lead Global QMS platform collaboration with IT:
Facilitate access and training of QMS users.
Drive QMS continuous improvement initiatives.
Ensure IT-specific QMS documents and practices are identified and supported in alignment with the Global QMS.
Execute business process and system ownership activities, as assigned.
Contribute to the creation and maintenance of quality related policies and procedures.
Serve as a Business Process and System owner for the assigned Quality owned systems.
Provide management oversight and direction to direct reports.
Perform other work related duties as assigned.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BS in Computer Science or equivalent degree and experience.
10 years' experience working in the pharmaceutical industry with a concentration in Computer Systems Quality Assurance.
Functional understanding of the drug development life cycle from discovery through post approval.
In-depth knowledge of 21 CFR Part 11, Annex 11 and GAMP 5 best practices, regulations and guidelines.
Extensive understanding of Data Integrity requirements.
In-depth experience with software development lifecycle methodologies.
Fluency in IT system structure and function.
Strong project management skills with the ability to prioritize and adapt to fast-paced business needs while operating in a regulated IT environment and upholding compliance with regulations and procedures as well as customer requirements.
Excellent written and verbal interpersonal communication skills to interact with colleagues of all levels.
Active participation in the relevant industry's organization (such as ISPE).
Global level experience is preferred.
Disclaimer: The above statements are... For full info follow application link.
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