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Manager, Quality and Compliance, Process and Records Management

Company: Katalyst Healthcares & Life Sciences
Location: Cambridge
Posted on: September 16, 2020

Job Description:

Manager, Quality and Compliance, Process and Records Management. Cambridge, MA. Contract. Company Description. Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.. Job Description. POSITION SUMMARY. The Manager, Process and Records Management will liaise and collaborate with clients functions to facilitate business process documentation, training compliance, records management compliance, PSMF and TMF inspection readiness state at all times.. ESSENTIAL JOB FUNCTIONS. 1. Facilitate Global R&D Controlled Document requirements. a. Support process and sub-process owners.. b. Provide oversight of change management for process implementation or update. c. Provide technical writing expertise for SABR process owners and sub-process owners. d. Facilitate discussions and lead projects specific to GxP process documentation. Work with subject matter experts, functional department personnel and key team members (both internal and external) to ensure timely development and accurate content of required documentation including initial process mapping through final process mapping and fully documented process. Recommend and facilitate revisions or changes in scope, formatting, and content as identified.. 2. Manage and maintain SABR learning requirements. a. Ensure SABR functions have clear training requirements. b. Oversee SABR course catalogue and manage training quality. c. Ensure proper development and delivery of required training. d. Author and/or collaborate with other department personnel on database user manuals, data convention manuals, training manuals and other department written training aids. e. Assist with managing training metrics oversight and strategy. 3. Implement and maintain SABR compliance with Biogen’s Global Record Management requirements. a. Support tracking of the authoritative source(s) for PV information. b. Perform maintenance activities for SABR archival strategy and resource plan. 4. Implement SABR TMF documentation quality strategy to meet GCP & GVP regulations. a. Support Document Quality Review. b. Support Completeness Review. c. Ensure oversight for inspection readiness of SABR TMF documentation. Possible Additional areas for support:. 5. Support PSMF strategy compliance with GVP regulations. 6. Manage / support biannual updates SABR MedDRA Expectedness and Expedited Lists to ensure quality and completeness.. 7. Support Audit and Inspections. QUALIFICATIONS. Education. B.A. or B.S. degree or equivalent required, science degree preferred. Experience. • Minimum 5 years of experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences highly desired. • Knowledge of FDA expectations is essential. • Knowledge of Post-marketing and Clinical Trial Pharmacovigilance regulations. • Direct experience in GCP compliant quality systems. • Regulatory affairs, quality assurance or clinical departments experience is preferred. • Understanding of Lean Six Sigma process principles. Skills. • The employee must have strong knowledge of pharmaceutical R&D regulatory affairs, technical writing skills, project management skills, drug safety knowledge, meeting facilitation and documentation skills.The position also requires leadership skills that provide solutions to complex problems across SABR functional areas, working closely with all stakeholders. Manager must possess ability to work with minimal direction, ability to exercise some latitude in determining objectives and approach to work assignment to maximize compliance, strong organizational skills, attention to detail, and technical skills, e.g., Microsoft Programs (Excel, Access and Word), Visio, and Adobe Acrobat Pro. Familiarity with ARISG and Trackwise.. Qualifications. B.A. or B.S. degree or equivalent required, science degree preferred. Additional Information. Good working knowledge of project management activities.. Interpersonal and professional skills to interact at all levels including senior executives, contractors and colleagues.. Good written and verbal communication skills and ability to present and critically discuss data in both internal and external discussions.. Highly organized, with exceptional good analytical and reasoning capability, ability to multi-task and prioritize.. Thorough knowledge on analytical & numerical skills.

Keywords: Katalyst Healthcares & Life Sciences, Cambridge , Manager, Quality and Compliance, Process and Records Management, Other , Cambridge, Massachusetts

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