Manager/ Senior Manager GxP Compliance
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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. Come join our team and make a meaningful impact on patients’ lives.
Manager or Senior Manager GXP Compliance
Under general supervision of management, this position will be the regional representative for the Corporate GxP Compliance function and is responsible for the oversight of GxP regulatory compliance programs, including oversight of inspections and inspection commitments. Responsibilities include designing, developing and implementing programs to assure compliance with corporate policies and regulatory agencies. The scope of the responsibilities include management of compliance metrics, completing assigned projects to enhance compliance, and supporting inspections.
The Manager receives assignments in the form of objectives and establishes goals to meet the objectives. The Manager has leadership responsibility regardless of reporting structure by providing guidance to senior leaders, peers and subordinates to achieve goals and complete tasks in accordance with the established department strategies. Outcomes are reviewed and measured based on meeting objectives and schedules.
The Manager works on problems of moderate complexity and diverse in scope, with broad impact across the organization. Exercises appropriate judgment within generally assigned areas to select methods and techniques for solving problems and removing obstacles. The Manager will act as leader in the organization to meet schedules and resolve technical problems. The Manager may be required to develop and administer budgets, schedules and performance requirements as necessary.
Regulatory Inspection Support
- Track regulatory inspection commitments through action, completion and verification.
- Provide guidance and support to site management on the design, selection, and implementation of systems/programs as they relate to GxP compliance.
- Keep abreast of industry and affiliated publications, memberships, and technologies to ensure organizational goals are met. Actively seek out new, cutting edge technology to further training initiatives and build efficiency.
- Work closely with internal functions to ensure GxP activities are addressed to support those functions.
- Support corporate policies in which all staff are required to follow defined processes and policies; behave in a professional manner with integrity and strive for right first time performance, and where Management is required to ensure staff are assigned appropriate curricula and have a combination of training, education and experience to execute assigned responsibilities.
- Support proactive compliance as a representative for emerging regulations; compliance intelligence and compliance metrics.
- Support the Corporate recall program.
- Performs a wide variety of activities to ensure compliance with applicable regulatory and requirements.
- Ensure GxP activities including legal agreements, quality agreements, temperature releases, deviation support, site visits, and audit support are completed in a timely manner.
- Develops, implements, and maintains systems, programs and processes to ensure compliance with GxP regulations.
- Safeguarding product users against potential hazards arising from poor distribution practices
- Ensure conditions of the relevant BioMarin distribution license requirements are met.
- Ensuring that the GDP quality management system is maintained.
- Focusing on the management of authorized activities and the accuracy and quality of records.
- Ensuring that relevant customer distribution complaints are dealt with effectively.
- Ensuring that suppliers, customers, and subcontracted activities for distribution activities are approved.
- Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
- Deciding on the final disposition of returned, rejected, recalled or falsified
- Approving any returns to sale-able stock.
- Maintain current regulatory knowledge by regularly using regulatory web sites as applicable to read any changes to guideline and regulations.
- Other duties as assigned
- BA/BS from an accredited school.
- 12+ years of experience with biotechnology, pharmaceuticals or human healthcare industries.
- Advanced Degree preferred.
- BA/BS or Advanced Degree in Business, Engineering, Law, Science or Technology.
- Lean and/or Six Sigma certification from a recognized certifying body or global organization engaged in Lean Six Sigma.
- Ten (10) or more years’ experience in a biologic or drug GxP environment
- Five (5) or more years’ experience in pharmaceutical Quality or Compliance Knowledge of GxP regulations.
- Program and/or Project management skills.
- Ability to lead multiple projects at a time and to shift between various projects as required.
- Experience with using and running reports from GxP database systems
- Audit or Inspection experience highly desirable.
- Demonstrated interpersonal (influencing and negotiating skills), leadership, planning, problem solving, team building & management, and organization skills.
- Excellent communication skills, both written and orally, across all levels of management and across different geographies and cultural backgrounds.
- Experience in use of Quality Tools such as benchmarking, gap analysis, pareto analysis, fish- bone diagrams, and process mapping for fact base decisions making is desirable.
Other skills and abilities:
- Motivated and self-directed team player with excellent interpersonal skills
- Must have ability to influence at all levels within the organization
- Must possess excellent facilitation and coaching skills
- Proficiency in using Microsoft Office or statistical analysis software
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.