SYSTEMS SOFTWARE VALIDATION MANAGER / LEAD
Long-Term Contract - Expect 1 year or more.
Significant Travel Required; some International
The Systems Software Validation Manager/Lead position will be expected to create, manage and participate in the oversight of GxP Computer System Validation (CSV) activities, including creation of validation artifacts and audits of vendors providing computerized systems or computerized system service providers. Assure that computer system validation work performed for a client and/or by various consultants at various locations (e.g., subcontractors and CROs) meets client expectations, regulatory, and internal requirements; participate in investigations related to GxP computerized systems; and author Validation Policy for a client.
Skill Set Requirements
Qualified candidates must have the ability, demonstrated by experience, to manage a large validation project and coordinate the efforts of multiple sub-projects.
The chosen Candidate will create, manage and participate in the oversight of GxP Computer System Validation activities, including creation of GAMP5 computer validation artifacts, audits of vendors providing computerized systems or computerized system service providers; participate in investigations related to GxP computerized systems in support of GMP and GCP activities and participation in investigations of related deviations and incidents.
In this role, the candidate will author Validation Policy for client(s); maintain current knowledge of cGxP regulatory issues and assure our related business needs are met; develop a support system of internal and external contacts to drive the decision making process within client; manage budgetary and cost issues within the quality function.
Candidates must have a minimum of 3 - 5 years experience with a consulting or world class quality organization and knowledge of computer systems validation related to pharmaceutical manufacturing, clinical development, QC/QA, and regulatory affairs and a strong appreciation of the impact of regulatory bodies on pharmaceutical, biologics, or medical device operations.
Candidates must have first-hand knowledge of computer system validation related to pharmaceutical manufacturing, clinical development, QC/QA, and regulatory affairs Quality processes and regulations (e.g., cGMP, GCP, and GLP regulations) or experience in drug manufacturing packaging, training and/or clinical development.
Candidate is to have experience in auditing computer system validation/software development life cycle (SDLC) processes, risk management, and to be literate of GAMP5 and GAMP V-model approach to software validation.
Candidate is capable of acting with a sense of urgency and enhances performance by doing things that are unique and takes well-calculated risks in decision making.
Candidate adapts easily to new circumstances and is flexible in a work environment that makes frequent changes in its demands; is able to work with a wide variety of diverse people and cultures. Candidate is to coach both internal and external employees on ways to improve performance and encourages the free exchange of information and opinion even when they may be negative or unpopular.
Education / Certification
Education/Experience Qualified candidates must have a Bachelors degree in physical, life, or computer sciences or a related field. PMI or SixSigma certification a plus.