Senior Director, Head of External Operations, GEO
3 weeks 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.
- Ensure delivery of quality product on time from our CMO network to support clinical and commercial supply plans, proactively resolving issues that escalate from Process Teams (Make – Assess – Release and Ready – Run – Release processes).
- Partner with MSAT, External Quality, and Partner Management team to oversee & support product launch programs, tech transfers, technical changes, labelling updates, etc.
- Manage the trades offs & risks between longer-term strategic programs & day-to-day supply activities.
- Develop the Operations model supporting the teams as they look to standardise work, eliminate waste and focus on cross functional working relationships to ensure product supply.
- Recruit, onboard, & train operations professionals to ensure the team has the appropriate experience & capabilities to provide oversight across the E2E pharmaceutical value chain.
- Manage career development & succession planning for external operations teams.
- Manage CMO performance and develop the CMO relationship through routine cycle of Business Review Meetings (BRMs), Quality Review Meetings (QRM), and Joint Steering Committee (JSCs) Meetings as well as ad hoc visits as needed.
- Lead our strategic roadmap to deliver against agreed targets (eg. lead time reduction, cost reduction, metrics enhancements).
- Partner with Quality, Site Supply Chain, MSAT, and others to develop cross functional goals to drive continuous improvement (Quality, Cost, Delivery, Customer Service) in CMO Operations.
- Represent CMO Operations in the Sales and Operations Planning process.
- Lead development and management of CMO Operations budget and long-range plan (approx. $200m+ annual spend).
- Support the CMO selection process by evaluating CMO capabilities against applicable manufacturing, quality and compliance requirements and needs of BioMarin – both operational capabilities & strategic objectives.
- Support development of strategic partnerships with CMOs.
- Partner with Compliance, Legal and Procurement teams to negotiate Master Supply Agreements with beneficial terms for BioMarin.
- Proactively manage and communicate operational risks across the CMO network and develop mitigation plans in partnership with other functional leaders.
- Develop risk-based strategies for the CMO operations oversight, considering the product life cycle, complexity and CMO capabilities.
- Develop CMO Operations team to ensure BioMarin continues to attract, retain, and engages key talent.
- Bachelor's degree in a Life Sciences, Chemistry, Chemical Engineering or Pharmaceutical Engineering discipline required.
- Minimum of 15 years of relevant biotechnology or pharmaceutical industry experience within operations, quality, or supply chain.
- 10+ years of direct experience in a GMP manufacturing environment and 7+ years of team leadership.
- Direct and broad experience in GMP manufacturing across multiple platforms (biologics; synthetics; oral dose; parenteral manufacturing; packaging).
- Experience overseeing multiple product launch / NPI / Tech Transfer programs.
- Experience with regulatory agency inspections (e.g., FDA, TGA).
- Previous experience leading global teams in multiple locations.
- Strong leadership track record and experience in operations management with CMOs or internal operations.
- Demonstrated ability to hire, coach and grow leadership talent.
- Experience in developing, implementing and leading a cross functional operations model.
- Strong focus and passion for Operational Excellence and Continuous improvement.
- Track record of delivery on operational improvements across Quality, Cost, Delivery and Customer Service.
- Strong leadership track record especially in the areas of leading in a global and matrix environment, working cross functionally and developing talent.
- Excellent written and verbal communication skills at all levels in the organization.
- Experience managing department budget / spend.
- Ability to travel 25-50%, when required.
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
-
Manager/Sr. Manager, External Quality Planner
3 weeks ago
Dublin, Dublin City, Ireland BIOMARIN Full timeWho 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...
-
Urban Mobility Partner Data Engineer, Geo
3 weeks ago
Dublin, Dublin City, Ireland Google Inc. Full timeUrban Mobility Partner Data Engineer, Geo corporate_fare Google place Dublin, Ireland Apply Bachelor's degree or equivalent practical experience. 3 years of experience coding in one or more programming languages.3 years of experience designing data pipelines, and dimensional data modeling for synch and asynch system integration and implementation using...
-
Director of Operations
3 weeks ago
Dublin, Dublin City, Ireland Sherpa Kids Head Office Full timeJob descriptionAre you passionate about shaping brighter futures for children? Do you thrive in dynamic environments where safety, quality, and excellence are top priorities? Sherpa Kids is seeking a talented individual to join our team as Director of OperationsAt Sherpa Kids, we're dedicated to providing enriching experiences for children across Ireland...
-
Head of Ground Operations
3 weeks ago
Dublin, Dublin City, Ireland Ryanair Full timeRyanair is hiring a Head of Ground Operations – Compliance to be part of Europe's Largest Airline Group.The role of Head of Ground Operations - Compliance is crucial within the company, ensuring continuous regulatory compliance for the Ground Operations function (Front of House & Ramp) across the network. The selected candidate will serve as the 'Nominated...
-
Head of Ground Operations
3 weeks ago
Dublin, Dublin City, Ireland Ryanair Full timeRyanair are currently recruiting for a Head of Ground Operations – Compliance to join Europe's Largest Airline Group.The Head of Ground Operations - Compliance is an important role within the company and is responsible for continued regulatory compliance for our Ground Operations function (Front of House & Ramp) around the network. The successful candidate...
-
Dublin, Dublin City, Ireland NLP PEOPLE Full timeMinimum qualifications: • Bachelor's degree or equivalent practical experience. • Candidates will typically have 1 year of experience in program management. • Typically 1 year of experience in solving machine learning or artificial intelligence challenges involving data analytics and statistics. • Experience with SQL or R, Python, or other...
-
Director, Head of Marketing
3 weeks ago
Dublin, Dublin City, Ireland TOMRA Collection Pty Ltd Full timeTOMRA Food is a multinational organisation and a leading provider of sensor-based sorting, peeling and integrated post-harvest solution for the food industries. Transforming global food production to maximise food safety and minimise food loss by making sureEvery Resource Counts, has been our strength for over 50 years.At TOMRA, we want people toinnovate,...
-
Head of Legal
1 month ago
Dublin, Dublin City, Ireland Cpl Full timeThe CCPC is seeking to recruit a Head of Legal to lead Legal Services in relation to the CCPC's competition law functions.The Role: This is an opportunity for an experienced lawyer, with excellent strategic leadership skills, to take on a senior management role overseeing the delivery of legal services in a dynamic and fast-paced public sector...
-
Senior Geo-environmental Consultant
1 month ago
Dublin, Dublin City, Ireland Stantec Consulting International Ltd. Full timeRedefine your personal best. Stantec's Environmental Services Team works closely with our clients to develop innovative, sustainable and efficient solutions to their needs. We are looking for driven individuals who think differently and love to challenge conventional thinking to join us in a growing, collaborative team of like-minded professionals working...
-
Senior Account Manager
3 weeks ago
Dublin, Dublin City, Ireland HOVER SENIOR LIVING COMMUNITY Full timeWe 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...
-
Operations Director
3 weeks ago
Dublin, Dublin City, Ireland Mitie Full timeOperations Director - Soft Services Team Operations | Permanent Full Time About Mitie Mitie offers facilities management services across Ireland, Europe, and the UK, tailored to meet clients' needs. Our service areas include technical services, energy and building services, cleaning, security, front of house, and consultancy. We strive to create exceptional...
-
Assistant Director of Nursing
3 weeks ago
Dublin, Dublin City, Ireland Grace Healthcare of Dublin Full timeThe Grace Healthcare Group are an established and renowned group of Nursing Homes throughout Ireland. We are currently seeking Assistant Directors of Nursing roles to support our Directors of Nursing in our Bishopscourt Residential Care centre in Co. Cork, and Glenaulin Nursing Home in West Dublin.Role of Assistant Director of NursingTo manage the delivery...
-
Special Missions Captain
3 weeks ago
Dublin, Dublin City, Ireland 2Excel Geo Full timeSpecial Missions Captain (Multi-Engine Turbine)2Excel Aviation Ltd is an industry leader in specialised and innovative solutions for aviation's most complex challenges and our success is based on the talented and experienced people that make up our workforce. Our Special Missions division delivers specialist aviation services to Government and industry...
-
Director of Operations
3 weeks ago
Dublin, Dublin City, Ireland Excel Recruitment Full timeOperations Director- Luxury Hotel- Dublin City Excel Recruitment are currently seeking an experienced and forward thinking Operations Director at one of Ireland's top Luxury 5 Star Hotel properties. This role will be alongside the General Manager in ensuring that all areas within the hotel are running smoothly and that the presentation of the hotel is to...
-
Operations Director
3 weeks ago
Dublin, Dublin City, Ireland Alpine Recruitment Group Limited Full timeAlpine Recruitment Group Limited East Wall Road, Dublin 3, IRL Operations Director Our Client is looking to appoint Operations DirectorResponsible for overall running of the company reporting to ownerPolicies & procedures, productivity & operationsOversee all project teams - Contracts Mgrs, PMs, Engineers etcPredominantly residential & commercial projects...
-
Operations Director
3 weeks ago
Dublin, Dublin City, Ireland Mitie Full timeOperations Director - Hard ServicesTeam Operations | Permanent Full TimeAbout MitieMitie provides a wide range of facilities management (FM) services across Ireland, Europe, and the UK. Our services include technical services, energy and building services, cleaning, security, front of house, and consultancy.We collaborate with private and public clients to...
-
Dublin, Dublin City, 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 the...
-
Digital, Associate Director
3 weeks ago
Dublin, Dublin City, Ireland Teneo external feed for LinkedIn Full timeThe Digital Communications Client Service role is at Associate Director level within Teneo and is responsible for making a significant contribution to the company's reputation, profitable growth and retention of clients.Digital Client Service Associate Directors have responsibility for helping leading client accounts and supporting teams to deliver to...
-
Dublin, Dublin City, Ireland Google Inc. Full timecorporate_fare Google place Dublin, Ireland Apply Bachelor's degree or equivalent practical experience.1 year of experience in program management.1 year of experience in solving machine learning or artificial intelligence challenges involving data analytics and statistics.Experience with SQL or R, Python, or other programming/scripting languages to...
-
Head of Finance
3 weeks ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeOur client is urgently looking to hire a Head of Finance to join their team.This is an amazing opportunity to work in the Not-for-Profit sector.Role Title:Head of FinanceReports to:Chief Executive Officer The role:·To support the CEO and Board of Management to ensure financial compliance and accountability in respect of the financial business of the company...