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Ipsen · 1 day ago

Manager, QA Operations

Cambridge (US)

Full-time

Onsite

Mid, Senior Level

$48.15/hr - $48.15/hr

5+ years exp

Ipsen Biopharmaceuticals Inc. is a mid-sized global biopharmaceutical company focused on transformative medicines. The Manager, QA Operations is responsible for ensuring compliance in clinical studies and medical quality activities, acting as a key partner for clinical teams and overseeing quality assurance processes.

BiotechnologyPharmaceuticalProduct Research

H1B Sponsor Likely

Responsibilities

For the clinical studies/programs assigned, works with the clinical and medical teams to ensure good clinical practices and relevant regulatory requirements are met

Ensure quality oversight of the clinical studies and programs within their remit and ensure consistency and standardization in operational methodology and processes in their management

Act as a key partner for to cross functional study teams, to provide quality assurance expertise and guidance

Monitor quality performance of the clinical studies/programs: data collection, targets definition, best practices promotion, improvement initiatives, and appropriate reporting

Escalate systemic problems and appropriate recommendations/solutions to management for immediate and long-term resolution

Reviews contracts with clinical vendors and partners to ensure compliance responsibilities are included

Other assignments as directed by QA management (e.g.: New projects)

Support the preparation of the clinical quality plan including analysis

Ensure quality of the clinical studies/programs initiated by the local (affiliate) as per a risk-based approach

Ensure timely assistance for quality related topics

Support Service Provider QA Operations in the quality oversight of SP activities

Escalate to Manager identified issues that need to be discussed during the oversight and/or steering committee

Contribute to integration process in collaboration with CM Quality System

Provide clinical quality related input to business functions

Support and facilitates implementation and continuous improvement for clinical quality and operational processes

Ensure proper management including documentation, investigation, and CAPA definition of major/critical Quality Events and potential Serious Breaches in GCP

Monitor the clinical regulatory environment to ensure the continued compliance of the quality system and subsequent implementation plans

Contribute to development of plans for quality documentation related activities

Contribute to training sessions as SME, by reviewing training materials or participating in presentations

Perform Risk Assessment and ensures communication to management and documentation in eQMS

Foster a culture of continuous process improvement by monitoring CAPA effectiveness and facilitating Quality Risk Management activities

Report CAPA status and metrics, escalating any issues regarding delayed timelines or ineffectiveness of CAPA, as needed

Ensure timely delivery by following up with CAPA owners and scheduling meetings as necessary

Quality Assessments

Contribute to preparation of the quality assessment plan through the identification of sub-optimal processes

Quality assessment execution: prepare agenda, interviews, opening, closing, reporting and CAPA follow-up

Contribute to inspection readiness activities

Contribute to GCP inspections and ensure smooth organization of the front office and back office

Provide responses and address questions and observations during inspection when observations are related to the role or responsibilities of the QA function

Follow-up implementation of CAPAs and ensure timely completion

Support the audit activities by providing necessary study information to global audit group for risk assessment and audit plan

Collaborate with R&D and GMA in the risk-based oversight of clinical service providers

Assist in resolving compliance issues at clinical sites, clinical SP, laboratories and other SP by providing an assessment of the impact of any deficiencies and follow-up of CAPA implementation and ensure timely completeness

Support global internal audits and implement CAPAs to address the issues raises

Develop and communicate Corporate Quality Objectives applicable to clinical research

Serve as liaison between the Global Quality System department and functional entities involved in clinical research

Share major deviations and serious breaches with the organization and ensure prevention across organization and alignment of CAPA

Respect and ensure compliance with applicable EHS regulations and procedures

Promote an EHS dynamic within the teams for the proper functioning of the EHS management system

Participate in the prevention of accidents at work by carrying out Managerial Safety Visits (MVS) for its employees

Qualification

Quality AssuranceClinical PracticesClinical Studies ManagementRisk AssessmentCAPA ManagementRegulatory ComplianceAnalytical AbilityLife Sciences DegreeQuality DegreeEnglishFrenchTeam Collaboration

Required

Minimum 5 years of relevant experience, including approximately 3 years of experience in a Quality position for Medical Affairs and/or Research & Development

Experience in interventional/non-interventional clinical studies

Experience in Good Clinical Practices – Good Pharmacovigilance Practices – Good Pharmaco-Epidemiology Practices

Bachelor's degree in life sciences, Quality, or other related field

English

Preferred

Analytical ability: Examines, recognizes and understands the essential elements of complex problems of which parts are partially unknown and is able to provide support with investigation methodology and definition of adequate CAPAs

Ability to work within a dynamic, global team

Master's degree or higher, preferably in Quality

French

Benefits

401(k) with company contributions

Group medical, dental and vision coverage

Life and disability insurance

Short- and long-term disability insurance

Flexible spending accounts

Parental leave

Paid time off

Discretionary winter shutdown

Well-being allowance

Commuter benefits

Company

Ipsen

Glassdoor3.7

Ipsen is a global specialty-driven biopharmaceutical company focused on innovation and specialty care.

Founded in 1929

Boulogne-billancourt, Ile-de-France, FRA

5001-10000 employees

http://www.ipsen.com

H1B Sponsorship

Ipsen 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

2025 (1)

2020 (1)