Associate Director/Director, Contract Testing Organization Quality Management & Operations
Location Cork, Ireland Workstyle Hybrid ApplyWho We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
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.
Associate Director/Director,
Contract Testing Organization Quality Management & Operations
Closing Date: Wednesday 11th Jun 2025
SUMMARY DESCRIPTION
The Director/ Associate Director of Contract Testing Organization Quality Management & Operations is responsible to lead, develop and manage the Contract Testing Organization (CTO) Quality department in alignment with the Vision, Mission, Long Term Plan, and BioMarin Values.
The position is strategic in the External Quality organization and will maintain responsibility, leadership, oversight, and management of quality-related activities with third parties Contract Testing Organizations worldwide including In-Country Test Laboratories.
The responsibilities consist of establishing the compliance profile and quality mindset for the team including planning, implementation, and management of applicable Method Transfers, Quality Systems, oversight of CTO’s and in-country testing.
The position consistently supports the External Quality strategy and translates the CTO Quality components into tactical roadmaps for quality compliant operations of commercial and clinical products control testing by third parties worldwide.
This position will work closely with and serve as a business partner to Site Quality Functions, Global Supply Chain, Analytical Services, Commercial Operations, and Clinical Operations. l.
RESPONSIBILITIES
•Ensuring a Quality Management System is implemented and maintained for the Quality oversight of external CTOs, including quality risk management, corrective and preventative actions, change control, measurement of performance indicators and management review.
•Developing a CTO oversight strategy, including:
oSelection: discovery, qualification, Master Service Agreement, Quality Technical Agreement, Statement of Work, Cost quotes
oPerformance monitoring: KPIs, evaluation, improvements, exit
oClassification: assessing risk level, risk escalation, mitigation plans
oManagement of the business relationship and business goals.
•Maintaining a Supplier Qualification Program and approving any subcontracted activities at CTO
•Providing quality oversight of external CTOs conducting control testing of commercial and clinical products; and technical quality leadership in control testing processes.
•Contributing to Market Launch assessments and implementing In-Country Test labs to support product launch and compliance.
•Providing quality oversight of Method Transfer to external CTOs and Project Manage Lab set-up as necessary.
•Supporting Product Quality Complaint investigations at CTOs
•Assisting with regulatory inspections and internal audits at CTOs
•Supporting the requests for submissions and filings in the control testing space
•Developing external Quality Control business processes, procedures and best practices.
•Contributing to External Quality goals/initiatives and managing mid-level/large cross-functional projects for the department. Collaborate with key stakeholders in projects to establish global standards and policies.
•Influencing the development of Quality objectives and long-range goals and supporting strategy realization through leading department projects and initiatives.
•Providing quality decision, direction, and leadership in assigned cross-functional workstreams.
•Ensuring adherence to company policies/procedures, regulatory licenses or clinical trial applications, applicable Quality and Technical agreements, industry standards, and GMP regulations.
•Defining CTO Quality staff roles, responsibilities, and accountabilities.
•Providing expert Quality Control direction to CTO Quality team.
Supervisory responsibility
•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.
Competencies
•Lead and influence a staff of Quality professionals and ensure the proper skill set and development for the team are aligned with BioMarin strategy.
•Resource planning alignment with strategic priorities.
•Lead the implementation and maintenance of quality management system, for the external Control Testing activities with BioMarin products.
•Deal with complex issues using critical analysis and develops ethical, reasoned solutions to meet both business and regulatory requirements.
•Influence the organization by communicating quality issues and decisions, which impact the business.
•Ensure adherence of CTO partners to requirements in the Quality and Technical Agreements
•Ensure adherence to company policies and procedures and applicable Quality and Technical Agreements
•Active participation to company business growth objectives for quality alignment.
•Identify and take advantage of opportunities to do something new and different, continuous improvement.
•Assist with regulatory external CTO inspections and regulatory requests for submission/filings.
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
•10+ years of progressive managerial 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
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
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.