Manager/Sr. Manager, External Quality Planner
4 months ago
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.
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
• 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.
• Support S&OP processes by aligning Quality Capacity requirements within the plan throughout planning cycles.
• Ensure data accuracy in ERP (e.g., Lot release lead times) for key Quality parameters.
• Primary Admin for BINOCS for External Quality with support from area specific admins
• Utilize tracking files and highlight potential delays regarding capacity concerns.
• 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)
• Establish and maintain KPIs for External Quality. Run performance reports and calculate weekly and monthly metrics.
• Develop KPI Dashboard – Power BI
• Support External Quality Continuous Improvement efforts
• Enhance and Lead External Quality Tier 3 meeting
• 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.
-
Manager, Supply Chain Planner
5 months ago
Dublin, Ireland Bristol Myers Squibb Full timeWorking 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...
-
Sr. Associate External Supply
2 weeks ago
Dublin, Ireland Cpl Resources Full timeCpl in partnership with our client Pfizer are seeking Senior Associate External Supply - Operations Quality, to join the team at their state of the art plant in Dublin, Grange Castle for a 12 month fixed term contract. This role has a hybrid working model. External Supply Operations Quality (ESOQ) is responsible for the Quality management of approximately...
-
Planner | Exectuive Planner | Senior Planner
4 weeks ago
Dublin, Ireland Penguin Recruitment Full timeJob Title: Planner | Executive Planner | Senior PlannerLocation: Dublin or CorkOne of Ireland's largest and most respected Town Planning Consultancies, with offices in both Dublin and Cork, is seeking talented Town Planners to join their dynamic and growing team. With a diverse range of clients across both public and private sectors, this consultancy...
-
Sr. Manager
4 months ago
Dublin, Ireland Amgen Full timeSr. Manager - Security Accountabilities State briefly the principle objectives of the position:The successful candidate will fundamentally take local accountability for the protection of Amgen People, Assets, Information and Reputation in the Ireland and Netherlands Amgen sites / locations. They will lead, position, support, integrate and influence the...
-
Dublin, Ireland Penguin Recruitment Full timeJob Title: Planner | Executive Planner | Senior Planner | Associate Location: Dublin or CorkThe Company:Penguin recruitment is delighted to be supporting one of Irelands largest planning consultancies, with offices in Dublin and Cork, that is seeking motivated Town Planners from Planner up to Associate level. As one of Ireland's largest consultancies,...
-
QA Specialist, External Quality
5 months ago
Dublin, Ireland TEAM HORIZON Remote Work Freelance Full timeDescription Team Horizon is seeking a QA Specialist for External Quality for our client, who are a leading biopharmaceutical company based in Dublin. In this role you will support ongoing quality assurance responsibilities in support of Contract Manufacturing oversight and quality systems. Why you should apply: This is an excellent opportunity to...
-
Construction Planner UK
10 hours ago
Dublin, Ireland E-Frontiers Ltd Full timeJob Title: Construction Planner Location: Onsite, UK Department: Construction Management Company Overview: We are a leading construction firm specializing in commercial infrastructure. We are committed to delivering high-quality projects on time and within budget, while fostering a collaborative and innovative work environment. Job Summary: We are seeking a...
-
Material Planner
1 month ago
Dublin, Ireland FAAC Technologies Full timeMaterial Planner FAAC Electronics Limited is dynamic and challenging electronics manufacturing company with an energetic team, located in the Citywest Business Campus (Dublin 24). We are part of FAAC Technologies, a world leader in access automation, parking and access control, employing more than 3,700 employees across 5 continents and 55...
-
Master Planner
5 months ago
Dublin, Ireland Jabil Careers Full timeJob Description For our site in Dublin, Ireland we are looking for Master Planner Position Summary: Master Planner is responsible to serve as the customer interface for the demand plan and shipment information, develop feasible operational plan and maintain ownership over the execution of the operational plan, achieve the...
-
Senior Planner
2 days ago
Dublin, Ireland GPC - Global Professional Consultants Full timeSenior Project Planner - 10742 Senior Project Planner required to work for one of Irelands leading main contractors to work on a range of Data Centre projects in Dublin. This role will be based out of the companies Dublin office and the successful candidate will report directly into the Project Directors. If you are a Senior Project Planner who is looking...
-
Sr. Validation Engineer
2 weeks ago
Dublin, Ireland Amgen Full timeAseptic Processing Validation Sr. Engineer - Level 5 The validation department performs sterilisation validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for primary and secondary Drug Product Manufacturing. An exciting opportunity has arisen for a Sr. Engineer for the HVAC...
-
Senior Manager QA/QP
2 weeks ago
Dublin, Ireland Amgen Full timeDescription 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, supply chain, etc....
-
Senior Planner
3 weeks ago
Dublin, Ireland GPC - Global Professional Consultants Full timeSenior Planner (Residential) An opportunity exists for a skilled Planner with over four years of experience to join a highly regarded Tier 1 Main Building Contractor. The successful Planner will be the lead Planner on the residential side of the business -responsible for several large apartment schemes. The successful planner must possess suitable expertise...
-
Senior Project Planner
5 months ago
Dublin, Ireland John Sisk and Son Full time#IJ Senior Planner - Dublin, Ireland To lead the planning management function for the Sisk group of companies. To set the standard for planning and project controls and regularly review the function in the preconstruction and construction phases. To develop a consistent approach and produce regular reports to feedback on progress and performance to...
-
Senior Project Planner
2 weeks ago
Dublin, Ireland Gertek Project Management Full timeGerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services partnering with many of the world's largest life science & technology companies We are seeking a senior project planner / project engineer to work with our client in the life science sector Responsibilities...
-
Senior Project Planner
5 days ago
Dublin, Ireland GPC - Global Professional Consultants Full timeSenior Project Planner - 8956 *** Hybrid Working Opportunity *** Senior Project Planner required to work for one of Irelands leading main contractors to work on a Data Centre project in Dublin. This role will be based out of the companies Dublin office and the successful candidate will report directly into the Project Directors. If you are a Senior Project...
-
Senior Project Planner
2 days ago
Dublin, Ireland GPC - Global Professional Consultants Full timeSenior Project Planner - 8956 *** Hybrid Working Opportunity *** Senior Project Planner required to work for one of Irelands leading main contractors to work on a Data Centre project in Dublin. This role will be based out of the companies Dublin office and the successful candidate will report directly into the Project Directors. If you are a Senior Project...
-
Senior Associate External Supply
2 weeks ago
Dublin, Ireland Cpl Resources Full timeCpl in partnership with our client Pfizer are seeking Senior Associate External Supply - Operations Quality, to join the team at their state of the art plant in Dublin, Grange Castle for a 12 month fixed term contract. This role has a hybrid working model. External Supply Operations Quality (ESOQ) is responsible for the Quality management of approximately...
-
Materials Planner
5 months ago
Dublin, Ireland Leggett & Platt Full timeWe, at Leggett & Platt Inc., are searching for a Supply Planner within our Beddingteam to help support our International Spring business. Did you know we have been revolutionizing the sleep industry since 1883? That’s right! In fact, we hold the original patent on a spiral steel coil bed spring, filed way back in 1885. Since then, we have been an industry...
-
Supply Chain Planner
2 months ago
Dublin, Ireland PSC Biotech Ltd Full timeAbout PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...