Current jobs related to Manager/Sr. Manager, External Quality Planner - Dublin, Dublin City - TN Ireland

  • Transport Planner

    4 weeks ago

    Dublin, Dublin City, Ireland Quality Freight Group Full time

    Quality Freight offers comprehensive freight solutions, from basic container transport to complex international transits using various modes of transport. Our dedicated team is committed to adding value for our customers, providing reliable and efficient services at every level.About the Role:This is a full-time Transport Planning role based in Dublin,...

  • Quality Systems Manager

    2 weeks ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    Jazz Pharmaceuticals is seeking a highly skilled individual to join our Manufacturing Quality Compliance team as a Sr. Quality Specialist. In this role, you will be responsible for performing key quality and compliance tasks, including reviewing internal and external SOPs, participating in the development and revision of SOPs, and leading the generation of...

  • Sr. Sales Manager

    2 weeks ago

    Dublin, Dublin City, Ireland Space Exploration Technologies Corp Full time

    SpaceX was founded under the belief that a future where humanity is out exploring the stars is fundamentally more exciting than one where we are not.Today SpaceX is actively developing the technologies to make this possible, with the ultimate goal of enabling human life on Mars.SR.SALES MANAGER (MARITIME) The Starlink Enterprise Sales team is hiring a local,...

  • Sr. Sales Manager

    4 days ago

    Dublin, Dublin City, Ireland SPACE EXPLORATION TECHNOLOGIES CORP Full time

    SpaceX was founded under the belief that a future where humanity is out exploring the stars is fundamentally more exciting than one where we are not. Today, SpaceX is actively developing the technologies to make this possible, with the ultimate goal of enabling human life on Mars.SR. SALES MANAGER (MARITIME)The Starlink Enterprise Sales team is hiring a...

  • Sr. Sales Manager

    4 days ago

    Dublin, Dublin City, Ireland SPACE EXPLORATION TECHNOLOGIES CORP Full time

    SpaceX was founded under the belief that a future where humanity is out exploring the stars is fundamentally more exciting than one where we are not. Today, SpaceX is actively developing the technologies to make this possible, with the ultimate goal of enabling human life on Mars.SR. SALES MANAGER (MARITIME)The Starlink Enterprise Sales team is hiring a...

  • Sr. Sales Manager

    3 weeks ago

    Dublin, Dublin City, Ireland SPACE EXPLORATION TECHNOLOGIES CORP Full time

    SpaceX was founded under the belief that a future where humanity is out exploring the stars is fundamentally more exciting than one where we are not. Today SpaceX is actively developing the technologies to make this possible, with the ultimate goal of enabling human life on Mars.SR. SALES MANAGER (MARITIME)The Starlink Enterprise Sales team is hiring a...

  • Sr. Sales Manager

    4 weeks ago

    Dublin, Dublin City, Ireland SPACE EXPLORATION TECHNOLOGIES CORP Full time

    SpaceX was founded under the belief that a future where humanity is out exploring the stars is fundamentally more exciting than one where we are not. Today SpaceX is actively developing the technologies to make this possible, with the ultimate goal of enabling human life on Mars.SR. SALES MANAGER (MARITIME)The Starlink Enterprise Sales team is hiring a...

  • Sr Manager, Quality

    4 days ago

    Dublin, Dublin City, Ireland Amgen Full time

    Senior Manager, Quality Description Quality and Compliance Oversight of a contract lab, CMO or a raw material SRE. Alignment with CTA / Marketing Application. Key Responsibilities Be an integral quality member of Amgen cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process...

  • Sr Manager, Quality

    15 hours ago

    Dublin, Dublin City, Ireland Amgen Full time

    Senior Manager, Quality Description Quality and Compliance Oversight of a contract lab, CMO or a raw material SRE.Alignment with CTA / Marketing Application.Key Responsibilities Be an integral quality member of Amgen cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development,...

  • P6 Planner

    5 days ago

    Dublin, Dublin City, Ireland NECTO Search and Selection Full time

    Project Planner - Consultancy NECTO Search and Selection are currently recruiting for a Construction planner for an Irish Construction consultancy. As a project planner, you will be involved in the programming, scheduling, and overall detailing of a range of projects in housing, civils, and date centre packages. As A Planner you will: Work with the project...

Manager/Sr. Manager, External Quality Planner

1 month ago

Dublin, Dublin City, Ireland TN Ireland Full time

Social network you want to login/join with:

Manager/Sr. Manager, External Quality Planner, DublinClient:

BioMarin

Location:

Dublin, Ireland

Job Category:

Other

EU work permit required:

Yes

Job Reference:

810a200001e8

Job Views:

9

Posted:

15.03.2025

Expiry Date:

29.04.2025

Job Description:

Who We Are

BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

SUMMARY DESCRIPTION

The Manager/Sr. Manager, External Quality Planner reports to the Director of QA CMO Operations and is responsible for oversight of processes to ensure on-time batch release for External Quality as per long range planning requirements. In addition, this role is responsible for alignment of Quality Capacity within the Supply Planning Cycle, including maintenance of associated master data. This role interacts with Senior level management to influence decision and policy making and participates in corporate development and improvement of systems and processes as required. The role also plays a key role in ensuring effective communication and streamlined processes within the External Quality and GEO organization, particularly in the context of Make, Assess & Release. This position will work closely with and serve as a business partner to External Quality functions, Global External Operations (GEO), Site Quality Functions (Novato and Shanbally Operations), and Supply Chain. RESPONSIBILITIES
  1. Ensure that the long-range planning and execution of CMO release, incorporating QC testing, QA Batch Record Review and QP release, meet the supply planning schedule requirements.
  2. Support S&OP processes by aligning Quality Capacity requirements within the plan throughout planning cycles.
  3. Ensure data accuracy in ERP (e.g., Lot release lead times) for key Quality parameters.
  4. Primary Admin for BINOCS for External Quality with support from area specific admins.
  5. Utilize tracking files and highlight potential delays regarding capacity concerns.
  6. Manage the handoffs and communications with key stakeholders/functions to establish and maintain visibility, alignment and adherence to the plan. (e.g., monthly report headlines, key initiatives update)
  7. Establish and maintain KPIs for External Quality. Run performance reports and calculate weekly and monthly metrics.
  8. Develop KPI Dashboard – Power BI.
  9. Support External Quality Continuous Improvement efforts.
  10. Enhance and Lead External Quality Tier 3 meeting.
  11. Other duties as assigned.
Supervision Received:

Works autonomously on the accomplishment of agreed upon goals and objectives. Proactively identifies and reports discrepancies from normal practices or procedures to senior management, recommending and implementing plans for improvements.

Expected area of competence:

Resource planning alignment with strategic priorities. Influence the organization by communicating quality issues and decisions, which impact the business. Active participation to company business growth objectives for quality alignment. Identify and take advantage of opportunities to do something new and different, continuous improvement.

Decision making:

Establish operational objectives within the team. Be involved in developing, modifying, and executing company policies and procedures that affect quality control operations. Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Ensure budget schedules and performance requirements are met.

EDUCATION

Must possess a Bachelor's degree in Sciences, biotechnology, chemistry, microbiology or equivalent. Advanced degree preferred.

EXPERIENCE

5 to 10+ years of experience within the quality function of the pharmaceutical health care industry or with regulatory agencies. Extensive knowledge and experience in pharmaceutical health care operations, quality control, quality assurance, and international regulations are essential. Proficient in cGMPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies; ISO 9001:2000 regulations. Proficiency with eQMS, LIMS, eCDMS and Office 365 preferred.

Range:

The range being broadcast for this role is at the Manager level. If the candidate's experience justifies Sr. Manager level, that will be considered and range reflected appropriately.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

#J-18808-Ljbffr