Be an early applicantLess than 25 applicants

Company

BioSpace · 13 hours ago

Manager, QMS Record Management (Contractor)

United States

Contract

Remote

Senior Level

7+ years exp

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BiotechnologyCommunities

Comp. & Benefits

H1B Sponsor Likely

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Responsibilities

Build world-class infrastructure to enable the management of records across the enterprise as part of digital transformation initiatives.

Lead the implementation, ownership, oversight, maintenance, and execution of strategies relating to the expansion of record management systems, principles, programs, and policies across the company.

Collaborate across Recursion to drive a quality-minded, innovative culture and identify next-generation, industry-leading technologies to support our records program.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Record ManagementRecord GovernanceRegulatory ComplianceFDA RegulationsISO 9001GxP RequirementsProject ManagementContent Management SystemsElectronic Quality Management SystemsDocument Management SystemMicrosoft Office SuiteGoogle WorkspaceSlackLearning Management SystemCross-Functional Collaboration

Required

Bachelor’s or Master’s Degree in scientific or technical discipline.

7+ years of relevant Record Management experience, in a biotech/pharmaceutical setting. Experience should include overseeing core quality systems, primarily, Record Management and Record Governance/Control.

Hands-on experience with controlled/regulated record lifecycle management, record review and approval process, access control, storage and retrieval, archival, distribution, record retention, internal record audits and regulatory compliance standards.

Strong project management skills with ability to manage multiple projects and execute in adherence to timelines.

In-depth knowledge of relevant regulations, examples include FDA 21 CFR Part 211, FDA 21 CFR Part 11, ISO 9001, ICH guidelines, and GxP requirements (GMP, GCP, GLP).

Excellent cross-functional collaboration, interpersonal, verbal, and written communication skills.

Demonstrated success in managing audits, regulatory inspections, and compliance with international regulations (FDA, EMA, MHRA).

Demonstrates sound analytical and problem-solving abilities to resolve complex issues that involve numerous components.

Able to operate in a dynamic, fast-growing biotech company with aggressive timelines and the ability to flex between setting strategic direction and jumping in to get the work done.

Preferred

Familiarity with Business Tools preferred: Content Management Systems (CMS), electronic Quality Management Systems (eQMS), Document Management System (DMS), Microsoft Office Suite, Google Workspace, Slack, Learning Management System (LMS)

Company

BioSpace

BioSpace is the leading online community for industry news and careers for life science professionals.

Founded in 1988

San Francisco, California, USA

11-50 employees

http://www.biospace.com/

H1B Sponsorship

BioSpace has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2020 (2)