BioMarin leads the biotechnology industry in delivering therapies for chronic and degenerative genetic conditions that reduce patients' quality of life and shorten life spans. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. BioMarin will continue to focus on advancing therapies that are the first or best of their kind and make a big difference in improving patients' lives.
This is a new role and an individual contributor position responsible for supporting the GxP Compliance computer systems and data integrity audit program. This will encompass risk based scheduling, execution and closure of audits using the audit management system (TrackWise). The program scope includes internal and contracted computer systems and cloud based software that are used in support of GMP/GCP/GLP and GVP operations. The position will work collaboratively with the Technical Operations, Developmental Sciences, IT and QA Computer System Validation groups to ensure compliance with corporate and global standards. This role requires an ability to interact with and influence staff at all levels; effective communication and escalation of compliance issues with a focus on achieving acceptable resolution and continuous improvement. The individual shall also provide counsel and interpretation of regulations and guidance to internal project team members and corporate partners. This position reports to the head of GxP Computer Systems / Data Integrity and may be remotely based or based in San Rafael, California.
- Contribute to a robust Computer Systems/Data Integrity Compliance program - a component of the overall GxP audit programs. This will require coordination with the leads and staff of the GMP, GCP, GLP and GVP audit programs.
- Support on-going health authority inspection readiness through the self-assessment program to include mock inspections and compliance with revised and emerging regulations.
- Schedule, plan, execute, and write-up compliance audit results for internal and / or vendor qualification / surveillance. Review and manage audit responses and audit closure activities.
- Support on-going health authority inspection readiness to include compliance plans to align with revised and emerging regulations as well as any resulting compliance commitments.
- Ensure Compliance Management is kept abreast of significant issues, status of commitments identified during compliance risk assessment activities, as well as actions being taken to improve the situation.
- Maintain current compliance knowledge via seminars, trainings and readings.
- 25% travel may be required, both domestically and internationally.
- Other duties as assigned.
- All staff are required to follow defined processes and policies; behave in a professional manner with integrity and strive for right first time performance. Management is required to ensure staff are assigned appropriate curricula and have a combination of training, education and experience to execute assigned responsibilities.
Minimum B.S. in Sciences or related field, or advanced degree.
- Candidate should have at least 5 years of experience in pharmaceutical, biotech and / or device QA/QC, manufacturing or compliance roles. Candidate experience could also include development, test, QA, release, or support roles in software vendor / service provider that has Health Authority regulated customer base (e.g., software vendor, SaaS, CRO, etc.).
- Candidate should be able to work in a fast paced and dynamic organization, have the ability to prioritize and manage multiple priorities. A solution oriented individual with working knowledge of one or more of the following:
- FDA, EU, Canadian, and other international regulatory requirements / standards for device, biologics and small-molecule, and / or pharmaceutical IT systems and data integrity.
- Experience interpreting regulatory requirements in the context of current guidance and current expectations of international regulatory bodies is required. Utilizes strong organizational, interpersonal and communication skills to plan and accomplish goals.
- Experience in a GxP environment is a must. Audit experience and experience working with global companies are a plus.