External QA Inspection Management Mgr / Snr Manager

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.

External QA Inspection Management Mgr / Snr ManagerClosing date for applicants-6th June Essential Job Functions:

• Develop strategy for and lead Inspection Readiness activities for external partners and external quality. Foster a culture of permanent inspection readiness. Oversee trending of key audit / inspection performance metrics. Report and escalate issues to management.
• Manage the site annual self-inspection program.
• Benchmark leading practices & identify opportunities to enhance IR capabilities.
• Provide guidance & direction to stakeholders on trends in recent regulatory inspections.
• Liaise with local and global colleagues to share learnings to ensure consistency across the network and alignment with global processes.
• Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures in conjunction with the accountable parties.
• Maintain the MAH licensing, working closely with regulatory colleagues to address license impacting changes.
• Support site Quality Systems and escalate any potential issues / trends.
• Support continuous improvement initiatives.
• Support facilitation of site quality management review and report generation.
• Other duties as assigned.

 The ideal candidate will have the following experience / skills:

• 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).
• 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. 
• There will be 10-20% travel associated with this position 

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.