Senior Manager, Quality Operations

3 weeks ago

Dublin, Dublin City, Ireland Bristol Myers Squibb Full time

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb Ireland

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units.

Ireland is home to External manufacturing's global headquarters, the business unit responsible for the management of manufacturing contract operations (CMO's) and ensuring reliable supply of product to patients across the Bristol Myers Squibb global network.

This includes management of, and working in conjunction with, third party contract manufacturers and internal manufacturing sites. In Ireland, External Manufacturing has two sites; Global Headquarters based in Dublin 15 and a distribution centre in Shannon, Co Clare.

The Role

BMS External Manufacturing is looking to recruit permanent Senior Manager, Quality Operations , reporting to the Associate Director, Quality Operations. The person covering this position will provide quality operations and compliance oversight management to Active Pharmaceutical Ingredient and intermediate contract manufacturing organisations (CMO) engaged by External Manufacturing within a cross functional team.

Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.

Key Duties and Responsibilities:

Proactively manage contract manufacturer relationships from a quality and compliance perspective. Build strong effective working relationships with CMO's Quality lead for a Virtual Plant Team (VPT) or managing a significant portfolio at a CMO Develop and manage the quality events, change control and market complaints programs in respect of contract manufacturers. Ensure an effective deviation management system is in place to deal with vendor non-conformances from third party suppliers. Review process validation protocols and reports and also process verification/campaign reports for CMO's where relevant. Ensure Quality by Design (QbD) principles are implemented for all new products at CMO's. Review and approval of process risk assessment, process verification reports for CMO's for intermediates and Active Pharmaceutical Ingredient (API). Support pre-approval inspections Manage all activities associated with vendor approvals Provide quality/compliance subject matter expertise to the wider Supplier Relationship Management, Global Procurement, Supply Chain and Manufacturing Science & Technology (MS&T) teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs, etc. Provide the requisite quality support to Global Bristol Myers Squibb (BMS) functional groups such as Global Regulatory/Chemistry Manufacturing and Controls (CMC) and the local country based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions, etc. Manage the quality metrics programs in relation to CMO performance Serve as the Quality Operations Leader in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties Prepare, negotiate and approve Quality Agreements and purchase specs with CMO's Review and approve the Annual Product Reviews submitted by the CMO's Support the Global BMS external auditing program by participation in audits of Third Parties as requested Mange information/provide information for quality council meeting Assess and implement corporate policies and directives Liaise with auditors of external vendors and suppliers. Review vendor audits to identify trends. Manage audit observation closure. Review and update CMO Bona Fides as required Carry out annual risk assessments for CMOs Review and update stability protocols as necessary Proactive management of direct reports as necessary Review and approving goals and objectives for direct reports Proactively manage the development of direct reports Carry out batch release as required In the absence of the Quality Associate Director / Director , Quality Operations Global API, the Quality Operations Senior Manager can act as designee:Review and approval of change controlsSignatory on Good Manufacturing Practices (GMP) documentationRepresentation at meetings

Note*: Travel will be required on a routine basis as part of this role (approx. 25%).

Qualifications, Knowledge and Skills Required:

Five years' experience in the pharmaceutical industry, specifically in API manufacture, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency. Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables first-hand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences, and interface with research & development. In depth knowledge of current Good Manufacturing Practices (cGMP) regulations pertinent to the United States of America (USA), European Union (EU) and other international markets. Ability to build relationships, partnerships and influence and/or enforce quality decisions at external manufacturers. Strong negotiation, communication and presentation skills across all levels both internal and external to BMS. Exhibits BMS BioPharma Behaviors. Strong analytical and problem solving skills

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

  • Global Head of Quality Operations

    3 weeks ago

    Dublin, Dublin City, Ireland Quality Analytics Full time

    The Head of Quality Operations is the Quality Business Partner for Alexion Operations, Information Technology (IT) and Product Development & Clinical Supply (PDCS). This role leads the strategy and execution for quality assurance and quality control at Alexion's Manufacturing Facilities and Contract Manufacturing Organizations (CMOs) worldwide. Strategies...

  • Global Head Of Quality Operations

    3 weeks ago

    Dublin, Dublin City, Ireland Quality Analytics Full time

    The Head of Quality Operations is the Quality Business Partner for Alexion Operations, Information Technology (IT) and Product Development & Clinical Supply (PDCS).This role leads the strategy and execution for quality assurance and quality control at Alexion's Manufacturing Facilities and Contract Manufacturing Organizations (CMOs) worldwide.Strategies will...

  • Senior Manager, IRT Development Supply Quality

    3 weeks ago

    Dublin, Dublin City, Ireland Quality Analytics Full time

    This is what you will do:The senior manager for IRT Development Supply Quality will provide quality oversight and support to the Product Development - Clinical Supply (PDCS) IRT team in ensuring adherence to quality standards in the setup, operation, and management of Interactive Response Technology (IRT) systems supporting our clinical studies.This role...

  • Senior Quality Operations Manager

    3 weeks ago

    Dublin, Dublin City, Ireland Viatris Full time

    Senior Quality Operations Manager page is loaded Senior Quality Operations Manager Postuler locations Damastown, Dublin, Ireland time type Temps plein posted on Offre publiée hier job requisition id R Rottapharm LimitedChez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre...

  • Quality Operations Manager

    1 month ago

    Dublin, Dublin City, Ireland Pfizer Full time

    Quality Operations Manager page is loaded Quality Operations Manager Bewerben locations Ireland - Dublin - Ringsend time type Vollzeit posted on Vor 3 Tagen ausgeschrieben job requisition id Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to...

  • Senior Quality Compliance Manager

    3 weeks ago

    Dublin, Dublin City, Ireland Viatris Company Full time

    Senior Quality Compliance Manager page is loaded Senior Quality Compliance Manager Apply locations Damastown, Dublin, Ireland time type Full time posted on Posted Yesterday job requisition id R Rottapharm LimitedAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a...

  • Senior Manager, Quality Operations, Drug Product, EMEA and Asia Pacific

    2 weeks ago

    Dublin, Dublin City, Ireland Bristol Myers Squibb Full time

    Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Senior Quality Assurance Manager

    1 month ago

    Dublin, Dublin City, Ireland Mace Full time

    At Mace, our purpose is to redefine the boundaries of ambition. We believe in creating places that are responsible, bringing transformative impact to our people, communities and societies across the globe. To learn more about our purpose, culture, and priorities, visit our strategy site. Within our consult business we harness our unique combination of...

  • Senior Account Manager

    3 weeks ago

    Dublin, Dublin City, Ireland HOVER SENIOR LIVING COMMUNITY Full time

    We are working with a company who are looking for a Senior Account Manager to join their team. The right candidate should be highly capable Communications and Public Relations Professional who is capable of handling a wide range of projects with a high degree of independence and sound judgement.About youAbility to "act up" for the Account Director when...

  • Senior Quality Compliance Manager

    3 weeks ago

    Dublin, Dublin City, Ireland Viatris Full time

    Senior Quality Compliance Manager page is loaded Senior Quality Compliance Manager Postuler locations Damastown, Dublin, Ireland time type Temps plein posted on Offre publiée hier job requisition id R Rottapharm LimitedChez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre...

  • Senior Operations Manager

    3 weeks ago

    Dublin, Dublin City, Ireland Maria Logan Recruitment Full time

    Senior Operations Manager Maria Logan Recruitment in Dublin City presents a fantastic opportunity for a dedicated and skilled leader to become part of one of the most impressive 4-star establishments in Dublin as a Senior Operations Manager. As the Senior Operations Manager, your main focus will be to supervise the daily hotel operations, while guiding and...

  • Senior Quality Operations Officer

    3 weeks ago

    Dublin, Dublin City, Ireland United Drug Full time

    Overview / Purpose of the RoleResponsible for providing quality support within the warehouse / distribution / manufacturing operations at United Drug – Goods Receipt, Stock Disposition, Returns, FMD support – in addition to reviewing quality standard for house-keeping , pest control and GDP documentation within the warehouse (s).Key...

  • Senior Operations Manager

    3 weeks ago

    Dublin, Dublin City, Ireland Maria Logan Recruitment Full time

    Senior Operations Manager - Dublin City Maria Logan Recruitment have an incredible opportunity for a passionate and talented leader to join one of Dublin Cities most impressive 4* properties as a Senior Operations Manager.As the Senior Operations Manager you will be responsible for overseeing the day-to-day hotel operations while leading and mentoring an...

  • PA2024276 - Senior Operations Manager

    3 weeks ago

    Dublin, Dublin City, Ireland SS&C International Managed Services Ltd. Full time

    PA Senior Operations Manager page is loaded PA Senior Operations Manager Apply locations Dublin, Ireland time type Full time posted on Posted 2 Days Ago job requisition id R22633 SS&C is a global provider of investment and financial services and software for the financial services and healthcare industries. Named to Fortune 1000 list as top U.S. company...

  • Senior Quality Compliance Manager

    3 weeks ago

    Dublin, Dublin City, Ireland Cloudsecurityexpo Full time

    Rottapharm LimitedAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via: Access - Providing high quality trusted medicines regardless of geography...

  • Quality Manager

    3 weeks ago

    Dublin, Dublin City, Ireland Meatex Trading Ltd. Full time

    The Quality Manager will report to the Senior Quality Manager. They are involved with the management of the Quality Assurance team and the Quality Control team.They will ensure that products are produced to the highest level of quality andcompliant with the specification of both the customerand relevant bodies. The Quality Manager will play a supporting...

  • Quality Manager

    3 weeks ago

    Dublin, Dublin City, Ireland Meatex Trading Ltd. Full time

    The Quality Manager will report to the Senior Quality Manager. They are involved with the management of the Quality Assurance team and the Quality Control team.They will ensure that products are produced to the highest level of quality andcompliant with the specification of both the customerand relevant bodies. The Quality Manager will play a supporting...

  • Associate Manager, GD Quality Operations

    3 weeks ago

    Dublin, Dublin City, Ireland Regeneron Pharmaceuticals, Inc Full time

    Associate Manager, Global Development Quality Operations & Partnerships (GDQOP) The Associate Manager in charge of Global Development Quality Operations & Partnerships (GDQOP) will provide support to the GDQOP team with Operations, Business Optimization, and Quality Partnerships (QP) activities, as needed. This role also involves assisting in general...

  • Senior Manager, Business Operations Cost Management

    3 weeks ago

    Dublin, Dublin City, Ireland Regeneron Pharmaceuticals, Inc Full time

    The Senior Manager, Business Operations Cost Management, is responsible for cost management activities related to running clinical trials and supporting Business Continuity efforts. The role involves providing measurements of cost, productivity, efficiency, and quality to support decision-making at Regeneron's clinical development portfolio. 25% of the...

  • Senior Manager, IRT Development Supply Quality

    3 weeks ago

    Dublin, Dublin City, Ireland Alexion Pharmaceuticals Full time

    This is what you will do:The senior manager for IRT Development Supply Quality will provide oversight and support to the Product Development - Clinical Supply (PDCS) IRT team, ensuring adherence to quality standards in the setup, operation, and management of Interactive Response Technology (IRT) systems for our clinical studies.This role will be critical in...