BioMarin Pharmaceutical Inc. logo
BioMarin Pharmaceutical Inc.

We transform lives through genetic discovery.

Director, GVP Compliance

ComplianceComplianceFull TimeRemoteLeadTeam 1,001-5,000Since 1997H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

97 days ago

Salary

Not specified

Seniority

Lead

Bachelor Degree10 yrs expEnglishGoogle Cloud Platform

Job Description

• Championing the implementation of Global Quality vision, policies, processes, and decisions • Collaborate with stakeholders to identify, communicate, and mitigate compliance risks • Continually enhance partnerships with key stakeholders and leaders across the business • Support and drive the implementation of quality and compliance projects and objectives • Stay updated on regulations and recommend proactive compliance changes when necessary • Develop and enhance GVP Compliance processes and best practices • Lead the execution of the GVP Compliance Global Audit Program • Act as a GVP compliance core team member on regulatory inspection teams and support mock readiness activities • Provide insights to continually optimize the GVP Compliance Audit Program • Contribute to Pharmacovigilance System Master File (PSMF) updates • Core team member and key contributor to the Risk Evaluation and Mitigation Strategies (REMS) compliance program • Create a high-functioning team to ensure GVP compliance and foster a culture of teamwork and mutual respect • Mentor and develop staff to achieve their full potential • Conduct management activities, including staffing, budget monitoring, and strategic planning • Manage recruiting, hiring, and evaluations with HR and Global Quality leadership

Job Requirements

  • 10+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance
  • Working knowledge of FDA, EMA, and global PV Regulations, and application of Good Pharmacovigilance Practices (GVP), ICH and GCP regulations
  • Experience working in Pharmacovigilance (PV) within Quality and Compliance
  • Experience executing or managing Health Authority Inspections
  • Experience executing or managing R&D Audits and GVP Audit Program
  • Experience with identifying optimal strategy for executing a GVP audit program working with internal auditors and external consultants
  • Experience navigating and understanding a quality management system
  • Core leadership competencies in strategic thinking, agility, prioritization, communication and decision making
  • Experience in managing staff and leading teams
  • Strong verbal, written and oral communication skills. Able to present to Senior Leadership. Able to work independently and be flexible to rapidly changing priorities.
  • Strong computer skills including working within the MS Suite of tools, and interfacing with Quality Management Systems

Benefits

  • Health insurance
  • Flexible working arrangements

Related Categories

Related Job Pages

More Compliance Jobs

Full TimeRemoteTeam 10,001+H1B No Sponsor

Manager of Conflict of Interest ensuring compliance at Beth Israel Lahey Health

United States
$100K - $130K / year
Shionogi Inc. (U.S.) logo

Director, Field Medical Affairs – COVID-19/Virology

Shionogi Inc. (U.S.)

Our mission is to supply the best possible medicines to protect the health and well-being of the patients we serve

Compliance98 days ago
Full TimeRemoteTeam 501-1,000Since 2001H1B No Sponsor

Director managing regional MSLs for COVID-19/Virology medical affairs strategies

New Jersey
$230K - $260K / year
Cordance logo

Senior Regulatory Affairs Specialist

Cordance

Making successful B2B SaaS businesses even better.

Compliance98 days ago
Full TimeRemoteTeam 201-500Since 2021H1B No Sponsor

Senior Regulatory Affairs Specialist at Ithos Global focusing on various regulatory tasks

United States
Point B logo

Senior Contracts & Compliance Specialist

Point B

We solve the world’s most complex business challenges through leading industry expertise and capabilities.

Compliance98 days ago
Full TimeRemoteTeam 501-1,000H1B Sponsor

Senior Contracts & Compliance Specialist managing contracts, licensing, and regulatory compliance functions

Washington
$65K - $129K / year