Cerevel Therapeutics · 2 days ago
Senior Quality Assurance Specialist, Global Product Quality
Wonder how qualified you are to the job?
Maximize your interview chances
Insider Connection @Cerevel Therapeutics
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.
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.
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)
Funding
Current Stage
Public CompanyTotal Funding
$1.9BKey Investors
Perceptive AdvisorsBain Capital Private Equity
2023-10-11Post Ipo Equity· $450M
2022-08-12Post Ipo Debt· $300M
2021-07-01Post Ipo Equity· $350M
Recent News
2024-06-04
Genetic Engineering and Biotechnology News
2024-06-04
2024-06-04
Company data provided by crunchbase