Manager, Quality and Compliance, Process and Records Management
Company: Katalyst Healthcares & Life Sciences
Posted on: September 16, 2020
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
Keywords: Katalyst Healthcares & Life Sciences, Cambridge , Manager, Quality and Compliance, Process and Records Management, Other , Cambridge, Massachusetts
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