QA Systems & Compliance Technical Manager

About BioMarin

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people's lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and several forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

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 coordinate the worldwide movement of our drugs to patients.

QA Systems & Compliance Technical Manager

12 month contract. 3 days onsite - Tuesday, Wednesday, and one other day. QA Systems & Compliance.

Essential Job Functions

• Act as a business process manager for applicable quality systems.
  • Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures in conjunction with the accountable parties.
  • Work with key stakeholders to identify and implement system improvements.
  • Analyse performance through metrics and trending.
  • Troubleshoot issues and support the business with queries.
  • Benchmark leading practices & identify opportunities to enhance systems.
  • Liaise with global colleagues to share learnings to ensure consistency across the network and alignment with global processes.
• Provide QA review and/or approval for Supplier Management and other Quality System activities impacting GxP operations, including (but not limited to):
  • Deviations
  • Changes
  • Specifications
  • Technical / Quality Agreements
• Provide additional support to Quality Systems and Compliance team:
  • Support audit and inspection activities for site, including preparation, participation, and follow up actions.
  • Lead activities associated with the site quality management review process.
• Other duties as assigned.

Qualifications & Experience Education

Bachelor's degree in Pharmaceutical Sciences, Process Engineering or related discipline.

Experience

• 10-15+ years experience within GMP regulated pharmaceutical or biotechnology environments
• 3 5 years in leadership roles, with experience in people management and a proven ability to influence cross functional teams and stakeholders.
• Significant hands on experience supporting regulatory inspections.
• Knowledge of EU GDP Guidelines and regional regulatory requirements.
• Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk.

Skills

• Excellent communication and influencing skills across all organizational levels.
• Planning and organising skills.
• Detail oriented, analytical thinker.

Note

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

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.