200+ applicants

Company

Original Job Post

Cerevel Therapeutics · 2 days ago

Senior Quality Assurance Specialist, Global Product Quality

United States

Full-time

Remote

Senior Level

5+ years exp

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Hiring Manager

Seema Dixit

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Responsibilities

Maintain and review Quality Events, Deviations, Investigations, CAPAs, Change Control, and Product Quality Complaints for R&D and Late Phase/Commercial GMP activities.

Review investigations to assure they are robust, properly documented (including root cause analysis, product quality impact assessment, CAPA), and adhere to procedures.

Write internal/vendor Change Controls, Quality Events, Deviations, Investigations, CAPA, and Product Quality Complaints and ensure they are properly documented in Veeva and inspection ready.

Maintain product quality complaint handling (documentation, coordination, investigation, resolution, closeout) and investigation processes for R&D and commercial products in compliance with regulatory requirements (21 CFR 210, 211) and internal procedures.

Escalate critical complaints, quality events, trends to senior management timely, per procedure.

Participate in the qualification, onboarding, and product training of call center for handling of commercial product quality complaints.

Support Annual Product Reviews as they relate to Quality System records. Support any potential stock recovery/recall, and/or field alert/field correction activities, if needed.

Work with internal stakeholders to establish and maintain feedback systems and other post-market surveillance processes.

Participate in internal audits and health authority inspections as required for the scope of work associated with this role.

Support GMP quality systems by driving regulatory compliance in accordance with applicable regulations and business objectives.

Additional Quality projects and responsibilities may be assigned based on the business needs of a growing organization.

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.

Quality system experienceTechnical writingRoot cause analysisCAPAsElectronic quality management systemGMP requirementsDrug development processCross-functional collaborationVendor managementProblem-solvingCommunicationFlexibilityOrganizational skillsAttention to detailRelationship buildingASQ CertificationSmall Molecule ExperienceTeam PlayerCustomer ServiceContinuous Improvement

Required

At least 5 years of relevant Quality System experience in a pharmaceutical industry supporting clinical and/or commercial products.

Technical writing experience; writing investigations, performing root cause analysis, and identifying CAPAs.

Experience working in an electronic quality management system (Veeva or equivalent).

Understanding of GMP requirements and the drug development process.

Ability to handle interactions and resolve issues with internal customers in a tactful, professional, and effective manner.

Strong verbal and written communication skills to effectively communicate with cross-functional business partners.

Highly motivated, flexible, and able to respond quickly to shifting priorities. Able to meet deadlines, with excellent organizational skills and keen attention to details.

Ability to partner and build relationships with technical operation stakeholders and external vendors to enable high-quality outcomes.

Ability to travel to Cerevel Headquarters in Cambridge, MA – may be up to 20%.

Preferred

ASQ certification, or equivalent.

Small molecule experience.

Strong team player with a solutions-oriented, customer-service, and continuous improvement mindset.

Company

Cerevel Therapeutics

Cerevel Therapeutics is a biopharmaceutical company that develops drugs to treat neurological and neuropsychiatric disorders.

Founded in 2018

Boston, Massachusetts, USA

201-500 employees

https://www.cerevel.com

H1B Sponsorship

Cerevel Therapeutics 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

Trends of Total Sponsorships

2023 (1)

2022 (2)