Senior Manager, Qc Planner

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Senior Manager, QC PlannerApply locations Cruiserath - IE time type Full time posted on Posted 3 Days Ago job requisition id R1589811
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Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.
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The Role BMS Cruiserath Biologics is seeking to recruit for a Fixed term contract, Senior Manager, QC Planner, reporting to the QC Director.
The QC Planner position is a senior individual contributor role within the QC Operations team.
The successful candidate shall be responsible for managing the Planning Strategy and execution for the Cruiserath Drug Substance and Drug Product site facilities and the Global Biologics Laboratory.
Key Duties and Responsibilities: Liaise with Supply Chain and Planning teams to create, maintain and communicate the QC testing schedule for the wider Global Biologics Network release testing.Liaise with onsite supply chain, schedulers, production and sample management to create, maintain and communicate the QC testing schedule for Cruiserath drug substance (DS), raw materials and environmental samples.Liaise with onsite supply chain, schedulers, production and sample management to create, maintain and communicate the QC testing schedule for the new Cruiserath Drug Product (DP) Facility.Work with the QC team leads to create weekly forecast of incoming routine and adhoc DS & DP lots which meet stakeholder needs and prioritize appropriately.Escalate any scheduling or prioritization issues as needed to ensure appropriate and timely mitigation.Maintain the QC Release dashboards to communicate DP release status to all stakeholders.Represent QC at the Drug Substance Disposition Huddles.Monitor and report on all QC metrics pertaining to testing such as TAT and RFT on a weekly and monthly basis.Create and maintain an S&OP business process for monthly monitoring of DP, DS and DP Tech Transfer volumes by liaising with the fill sites and Supply Chain Leads.Create and maintain a business process to ensure all requests for nonstandard work (including complaints, hold time exceedance, ship on test or expedites) are received, scheduled and communicated to the impacted QC teams.Compile the list of related medias and Buffers for each Drug Substance lot, tracking completion of testing and documenting completion through memos issued to QA.Responsible for driving adherence to QC Turnaround times for Drug Substance and Drug Product Lots, through tracking fora on a weekly basis.Responsible for co-ordinating the issuance of all Drug Substance and Drug Product CoAs.Responsible for creating and maintaining a standard request process for adhoc testing requests and adhoc information requests et system.Responsible for Product Record Attainment tracking and adherence on a monthly basis.Responsible for creating and maintaining a robust capacity planning process.Responsible for preparing and submitting planning forecasts in support of budget planning.Qualifications, Knowledge and Skills Required: Minimum of a BSc in Biochemistry or related discipline.Minimum of 5 years hands-on experience in a GMP Laboratory Setting.Strong background in quality control and regulatory compliance of commercial biologics in an FDA regulated environment.Knowledge of finished product manufacturing as well as analytical testing.Be very familiar with US and EU cGMP regulations and guidance.Experience with direct FDA, EMA, and Global HA interactions including face-to-face interactions and/or regulatory filings.Demonstrated leadership skills and outstanding interpersonal, communication and motivation skills.Excellent written and verbal communication skills and experience of working with teams and influencing decisions.Have experience leading cross-functional teams and knowledge of applicable regulatory inspections is desirable.Why you should apply: You will help patients in their fight against serious diseases.You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.You'll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.BMSBL
#LI-Hybrid If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.
You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science", every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work.
This structure includes site-essential, site-by-design, field-based and remote-by-design jobs.
The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility.
Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.
For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.
For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to ******.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:
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We're creating innovative medicines for patients fighting serious diseases.
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