- Be the Quality expert for European CMOs and CTOs.
- Build strategic relationships with CMOs and CTOs within the Quality organization and participates in Business Review Meetings to ensure Quality issues are raised and addressed, as necessary.
- Negotiate, monitor and maintain Quality Agreements with CMOs.
- Lead/Support/Execute Quality oversight for clinical and product commercialization activities.
- Lead quality process monitoring of the CDMO.
- Execute change management and vendor notifications as part of product life cycle management.
- Liaises with cross-functional teams for external quality commercial operations in support of GMP manufacturing and testing activities.
- Leads/executes continuous improvement activities and drive quality remediation.
- Work closely with the Audit and Inspection Quality Function to establish the audit strategy for Auditing and Performance oversight and support technical site audits including preparation for regulatory inspections.
- Establishment of vendor quality oversight processes including qualification, risk categorization and routine monitoring.
- Provide guidance and support through Quality representation in relevant geographies at periodic intervals on site at the CDMOs.
- Supports root cause analysis and product impact assessments for investigations resulting from deviations and OOS.
- Participate in Cell & Genetic Program and Quality projects.
- In-depth understanding on International regulations and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
- Experience in product life cycle from discovery and/ or commercial product development.
- Broad technical knowledge in cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
- Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
- Substantial experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)
- Excellent communication skills and a proven track record influencing/building/promoting a culture of Quality and Excellence.
- Ability to apply risk management principles to decision making and operational priorities.
- Substantial background in managing complex projects or teams within stated objectives and timelines and with a strong understanding of the underlying business drivers.
- Bachelor's degree or Master's degree or PhD in relevant subjects.
-
Operations Quality
Found in: Jooble UK O C2 - 1 day ago
Worldwide Clinical Trials, LLC England, United KingdomWorldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company's sc ...
-
Quality Operator
Found in: Jooble UK O C2 - 6 days ago
Hales Group England, United KingdomYou will be working Monday to Friday each week and have full Flexibility during peak trading periods (may include evenings and weekends) · Ensure product policies/procedures/checks are followed at all times · Flexible approach, open to change and has the ability to be multi-skill ...
-
Quality Operations Administrator
Found in: Jooble UK O C2 - 6 hours ago
Erodex United KingdomJob Application – Business Central Application Administrator · Business Central Application Administrator , Erodex · Erodex (UK) Ltd are looking for a high calibre candidate to join the IT department as Business Central analyst, working with the team to complete the implementat ...
-
Quality Operations Lead
Found in: Jooble UK O C2 - 5 days ago
Work180 United KingdomThis is a in-person and individual contributor role in our Bellevue, WA office which requires you to be located in the Greater Seattle area. · As a member of the CTO Strategic Initiatives team, your role will be responsible for driving the successful planning, execution, and del ...
-
Quality Operations Team Lead
Found in: Jooble UK O C2 - 6 hours ago
Terry Soot MG London, United KingdomTerry Soot Management Group (TSMG) is a field data collection company founded in 2017 in Europe.We collect data where automation is not possible. We count features, take pictures, make videos, record speech, and scan areas for every detail you need to make more informed decisions ...
-
Quality Nonsense: Operations Manager
Found in: Jooble UK O C2 - 6 hours ago
Philpar United KingdomQuality Nonsense is a rapidly growing startup that's looking for someone like you to help take the operations side of our business to the next level. · About Us · Our journey began 16 years ago, building a small remote team that now spans five continents and eight countries. We ...
-
Associate Director, Operational Quality
Found in: Jooble UK O C2 - 5 days ago
Vertex Pharmaceuticals London, United KingdomAssociate Director, Operational Quality (External Manufacturing) page is loaded · Associate Director, Operational Quality (External Manufacturing) · Apply locations Paddington, United Kingdom time type Full time posted on Posted 8 Days Ago job requisition id REQ-21741 Job Descr ...
-
Machine Operator/Quality Control
Found in: Jooble UK O C2 - 6 hours ago
IS2 Staffing Services London, United KingdomIS2 is looking for a Machine Operator for a growing manufacturing business that builds thermoplastic injection moulds for an automotive industry. Be part of a great team and help build your career in the manufacturing workforce. The ideal candidate for this role will be open-mind ...
-
Operations Quality Team Lead
Found in: Jooble UK O C2 - 3 days ago
Internetwork Expert London, United KingdomINEOS Automotive – Grenadier – Built On Purpose · Since Sir Jim Ratcliffe announced Project Grenadier in 2017, our team at INEOS Automotive has grown rapidly. From a start-up to the scaled business we are now, we've hit some huge milestones along the way. Delivering quality work ...
-
Deputy Quality Operational Excellence Manager
Found in: Appcast UK C C2 - 5 days ago
Insignis Talent London, United KingdomDeputy Quality Operational Excellence Manager – London – £70,000 + Car Allow + Fuel Allow. + Bonus + Ex. Benefits – Permanent · Primary Purpose: · Lead and actively participate in our client's quality improvement initiatives across operational departments by leading projects fo ...
-
Content Quality Analyst-operation Support
Found in: Ziprecruiter UK C2 - 1 day ago
TikTok Greater London, United KingdomJob Description · TikTok LIVE - Content Quality Analyst - Operations Support (German Speaking) · Responsibilities · About TikTok · TikTok is the leading destination for short-form mobile video. Our mission is to inspire creativity and bring joy. TikTok has global offices includin ...
-
Deputy Quality Operational Excellence Manager
Found in: Jooble UK O C2 - 6 hours ago
Insignis London, United KingdomDeputy Quality Operational Excellence Manager (Fluent French required) - London - £70,000 + Car Allow. + Bonus + Ex. Benefits - Permanent · Primary Purpose: · Lead and actively participate in our client's quality improvement initiatives across operational departments by leading p ...
-
Deputy Quality Operational Excellence Manager
Found in: Jooble UK O C2 - 6 hours ago
Insignis London, United KingdomDeputy Quality Operational Excellence Manager (Fluent French required) - London - £70,000 + Car Allow. + Bonus + Ex. Benefits - Permanent · Lead and actively participate in our client's quality improvement initiatives across operational departments by leading projects focused on ...
-
Deputy Quality Operational Excellence Manager
Found in: Jooble UK O C2 - 5 days ago
Insignis London, United KingdomDeputy Quality Operational Excellence Manager - London - £70,000 + Car Allow. + Bonus + Ex. Benefits - Permanent · Lead and actively participate in our client's quality improvement initiatives across operational departments by leading projects focused on root cause analysis of qu ...
-
Deputy Quality Operational Excellence Manager
Found in: Jooble UK O C2 - 3 days ago
STR Group Limited London, United KingdomDeputy Quality Operational Excellence Manager - London - £70,000 + Car Allow. · + Bonus + Ex. · Benefits - Permanent · Lead and actively participate in our client's quality improvement initiatives across operational departments by leading projects focused on root cause analysis ...
-
Regulatory Compliance Quality Operations Manager
Found in: Jooble UK O C2 - 1 day ago
Worldwide Clinical Trials, LLC England, United KingdomWho we are · Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in ou ...
-
Deputy Quality Operational Excellence Manager
Found in: Jooble UK O C2 - 6 days ago
Insignis Talent London, United KingdomDeputy Quality Operational Excellence Manager (Fluent French required) – London – £70,000 + Car Allow + Fuel Allow. + Bonus + Ex. Benefits – Permanent · Lead and actively participate in our client's quality improvement initiatives across operational departments by leading projec ...
-
Deputy Quality Operational Excellence Manager
Found in: Jooble UK O L C2 - 4 days ago
Insignis Talent London, United KingdomDeputy Quality Operational Excellence Manager – London – £70,000 + Car Allow + Fuel Allow. + Bonus + Ex. Benefits – PermanentPrimary Purpose:Lead and actively participate in our client's quality improvement initiatives across operational departments by leading projects focused on ...
-
Deputy Quality Operational Excellence Manager
Found in: Jooble UK O C2 - 5 days ago
Insignis London, United KingdomDeputy Quality Operational Excellence Manager - London - £70,000 + Car Allow. + Bonus + Ex. Benefits - Permanent · Primary Purpose: · Lead and actively participate in our client's quality improvement initiatives across operational departments by leading projects focused on root c ...
-
Deputy Quality Operational Excellence Manager
Found in: Jooble UK O C2 - 6 days ago
STR Group Limited London, United KingdomDeputy Quality Operational Excellence Manager (Fluent French required) - London - £70,000 + Car Allow. · + Bonus + Ex. · Benefits - Permanent · Lead and actively participate in our client's quality improvement initiatives across operational departments by leading projects focuse ...
Associate Director, Operational Quality - London, United Kingdom - Vertex
Description
Job Description
The Associate Director, Operational Area Quality will be responsible for leading the day-to-day Quality operations of Contract Manufacturing Organizations (CMOs) for Cell & Genetic Programs through the lifecycle development process. This includes quality oversight for the selection, qualification and routine monitoring of Contract manufacturers. The role will assure Quality oversight for technical and operational CDMO activities from clinical throughout product commercialization activities, post-approval process monitoring and change management. The role is also responsible for the development and maintenance of relationships with the external vendors, to drive compliance, monitor performance and support continuous improvement activities.
The quality role will closely partner with operational stakeholders and participate in associated governance for the successful planning and execution of the product life cycle Management. The successful candidate will be a key member of the Vertex Cell & Genetic Therapy Quality Team and the Virtual Product Team.
Key Responsibilities:
Key Requirements:
Education:
This position is Hybrid and requires min 3 days per week in the London office.