Sr. Manager, GxP Compliance AuditLocation Apply
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.
By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
This position will play a key role in executing BioMarin's Clinical Compliance (GCP) Program. The overall purpose of this program is to ensure continuous compliance with applicable global regulations and BioMarin clinical requirements through periodic assessments of internal and external operations related to clinical activities.
This role will support the BioMarin global GxP Compliance Program:
- Prepare and lead complex GCP audits across multiple, internal sites and third parties both domestic and international.
- Domestic and International travel required (~50%) to perform audits and related activities
- Annual Audits = 20 (75% domestic – 25% international)
- 2-3 trips to headquarters for work meetings
- Assure the integrity and quality of clinical data through the independent management, leading, participation and follow-up of routine and directed; internal and external; domestic and international GCP audits. Audits include, but are not limited to vendors, study reports and internal systems.
- Assist in the review and identification of potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation.
- Escalate issues of critical noncompliance
- Lead remediation efforts in a collaborative manner.
- Assess responses for adequacy
- Independently review audit observation responses for accuracy and overall effectiveness. Ensuring mitigations will address deficiencies as well as prevent future occurrences.
- Participate in due diligence activities and process improvement initiatives, as requested
- Work closely with functional leadership to manage current issues and anticipate upcoming auditing needs outside of assigned programs
- Other duties as assigned
This position is responsible for executing all facets of GCP audits. Also responsible for evaluating and improving GCP compliance levels and inspection readiness of BioMarin sites.
Acts independently to determine methods and procedures on new or special assignments. Works on complex problems and significant issues where analysis of situations and data requires an in-depth evaluation of variable factors. Exercises independent judgment in reviewing, developing and negotiating appropriate audit responses. Creates formal networks with key contacts outside own area of expertise, involving coordination among groups.
*Preference for East Coast candidates
Bachelor’s with a life science focus. Advanced degree in scientific discipline is a plus.
- Extensive knowledge of GCP regulations with 10+ years of experience within a regulated healthcare industry. Experience with other GXP’s is a plus.
- Ideal candidate will have broad experience in conducting GCP audits including vendors such as CROs, clinical and bioanalytical laboratories, central imaging /central reading, home healthcare agencies, translation companies, central IRBs and biospecimen storage facilities.
- Working knowledge of FDA Regulations, local country regulations, application of Good Clinical Practice.
- Strong verbal, written and oral communication skills. Able to present business indicators to Senior Management.
- Able to work independently and be flexible to changing priorities.
- Strong computer skills including word processing, spreadsheets, and presentations.