Senior Assessment Manager, GCP Compliance

Location:  San Rafael, California Category: Clinical

Description

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 Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

This position is responsible for supporting the assigned clinical program(s) as the GCP Compliance lead and key point of contact.  It requires building and maintaining strong relationships with multiple internal and external team members and cross functional groups. 

 

Strong knowledge of global GCP Regulations, and excellent communication and organizational skills are required. In order for the candidate to be successful in this position, the candidate must possess dynamic interpersonal and teamwork skills.

 

RESPONSIBILITIES

·       Act as a subject matter expert by providing GCP Compliance advice to the assigned clinical program(s), including updates for applicable regulations.

·       Provide assistance or guidance to the responsible parties in developing and completing corrective and preventive action plans.

·       Provide reviews of protocols, amendments, and other study specific documents as requested for consistency and acceptable standards and practices to ensure compliance with internal standards, regulations and ICH GCP guidelines.

·       Assist with tracking GCP Compliance audit trends and group metrics.

·       Report significant and/or serious ongoing quality deficiencies to GCP Compliance Management.

·       Assure the integrity and quality of clinical data by independently manage, lead, participate, and follow-up on routine and directed; internal and external; domestic and international GCP audits for the assigned program(s).  Audits include, but are not limited to: investigator study sites, vendors, study reports, and internal systems.

·       This position will require domestic and international travel around 20-25% of the time.

 

 

 

 

EDUCATION

Bachelor's degree in science field required, Master’s Degree preferable

 

EXPERIENCE

Minimum 12 years experience in the Pharmaceutical, Biotechnology or Medical Device industry; in Clinical Quality Assurance/Regulatory Compliance or equivalent.

  • Current knowledge of US Code of Federal Regulations and ICH Guidelines governing clinical trials and recent initiatives.
  • Must be detail oriented, with excellent oral and written communication skills.  Also, must be able to partner with a diverse group of staff/international consultants with different strengths and skills and have the ability to prioritize work, manage multiple projects, while maintaining quality.
  • Ability to work independently and as part of a team in a very busy work environment.
  • Experience in international compliance and auditing.
  • Experience with Regulatory Authority Inspections, including sponsor and clinical site preparation and support, is preferred

·       Auditor certification is a plus.

CONTACTS

  • GxP Compliance
  • Clinical Operations
  • Clinical Science
  • Development Science Quality
  • Clinical Data Management
  • Medical Writing
  • Regulatory Affairs
  • Pharmacologic Sciences
  • Medical Affairs
  • Clinical Investigators
  • Study Site Personnel
  • Clinical Service Providers


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.