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.

Technical Manager Quality Systems and Operational Readiness (External Quality)

• Leading the Quality oversight of technical transfers and Commercial Readiness within Global External Operations (GEO).
• Supporting the application of BioMarin’s Quality Policies & Procedures throughout precommercial operations within GEO.
• Owning Quality oversight for process, packaging and shipping validation activities.
• Collaborating with BioMarin’s GEO MSAT, Engineering and Contract Manufacturing Organization (CMO) Operations functions to deliver and sustain compliant products and processes.
• Ensuring applicable Medical Device standards are applied in the development and introduction of combination device manufacturing processes at CMO’s

• Provide Quality oversight for validation activities throughout the validation life-cycle across a broad range of validation disciplines including, but not limited to:
• New & modified Facilities, Utilities & Equipment (FUE)
• Process Validation for Drug Substance, Drug Product and Packaging processes at CMO facilities
• Shipping Qualification for thermal and non-thermal shipping configurations
• Act as Quality lead for Technical Transfers of BioMarin’s manufacturing processes to CMO’s focusing on establishing robust Quality Assurance control systems in partnership with the CMO’s to develop planned, predictable performance.

• Provide QA oversight of major changes to processes and equipment used in the production of BioMarin’s products at CMO’s to ensure continued compliance with product licenses, regulatory requirements, and releases specifications.
• Own initiation and revision of Quality Technical Agreements with CMO’s to clearly define GMP requirements and responsibilities for both parties in line with ICH QMP guidelines.
• Support major deviations at CMO’s tied to technical projects including leading or participating in process review, root cause analysis and corrective action assignment. Schedule and lead subsequent Material Review Boards (MRB’s) to determine disposition of material affected by the deviation.
• Review and approve batch records that are executed in pre-commercial phases (e.g., clinical, process performance qualification).
• Review and release lots that are manufactured in pre-commercial phases (e.g., clinical, process performance qualification).
• Provide QA Validation review and approval of validation activities related to the implementation of changes to validated methods, systems and processes while exercising judgment within broadly defined procedures and practices to establish approval criteria and identify and implement solutions.
• Ensure compliance with BioMarin Global Policies, through development, review and approval of validation master plans, guideline documents and SOP’s.

• Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin.
• Lead, and represent External Quality in, multi-departmental meetings & project teams.
• Identify and implement improvements to the External Quality systems.
• Participate in the change control program for modifications to qualified systems.
• Approve material and component specifications, Bill of Materials, and process instructions for new and existing processes.
• Participate in validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, Supply Chain Logistics, Planning and others.
• Participate in development and implementation of global alignment projects with BioMarin’s sister sites.
• Lead continuous improvement initiatives based on user feedback, process monitoring results, observations and responses.
• Development and reporting of process metrics.
• Administer applicable electronic systems.
• Assist as needed in audits and inspections.
• Interact with senior internal personnel and external partners on significant matters often requiring coordination across facility locations.
• Other duties as assigned.

• Bachelor’s Degree in science or engineering
• Minimum 10+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting
• Knowledge of US and EU GMP and ICH guidelines
• Quality Systems/GMP/Regulations - Working knowledge of GMP Quality Systems and cGMP Regulations (e.g., deviations, change controls, lot release, annexes).
• Partner oversight, risk and project management
• Demonstrated conversational English language skills
• Strong written and verbal English language
• Experience in Validation / Quality Oversight of CMO’s
• Tech Transfer Project and project management experience desirable.
• Decision Making/Problem Solving – Identifies problems and be able to lead and handle complex situations (e.g. major investigations). Collect input from key stakeholders in making sound and effective decisions and ensure the solutions and approach are aligned within and across teams.  Be decisive and move to action in the absence of clear information. Be proactive in implementing process improvements.
• Influence and Collaboration – Success in working in a matrixed organization and a global team. Demonstrates effective communication and interpersonal skills that brings cross functional teams together to reach a shared goal. Possesses strong verbal and written communication skills and the ability to influence at all levels.
• Agility – Ability to pivot quickly and recover constructively from setbacks, while continually learning and modifying approach.
• Leadership – Ability to interact with and provide leaders with guidance and recommendations to assist with decision making. Ability to facilitate meetings, influence stakeholders, and manage teams effectively in project execution.

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.