Senior Associate, Clinical Quality Operations

Location:  Novato, California Category: Quality

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 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.

The Role

 This position reports to the Director / Supervisor/ Manager/ Senior Manager, Clinical Quality Operations and is responsible for quality oversight for processes relating to the development, manufacture and testing of clinical material made for BioMarin

The responsibilities in the role include the following:

Provide Direct observation of Pilot Plant operations for adherence to GMP.
  • This includes direct coaching and mentoring of Pilot Plant staff, real time review of documentation and observation of critical process steps.
  • Provide direct observation of Analytical Sciences GMP testing for adherence to GMP / GLP. This includes direct coaching and mentoring of Analytical Sciences staff, real time review of documentation and observation of critical tests / laboratory operations.
  • Review of GMP documentation from Pilot Plant, Analytical Science, including log books, batch records and test records.
  • Review and approval of SOP and Batch Record revisions initiated by Technical Development (Pilot Plant, Analytical Sciences, other areas).
  • Review and approval of quality system records including change requests, deviations and CAPA for Technical Development (i.e. Pilot Plant, Analytical Sciences, Process Development).
  • Oversee manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations.

Core Competencies

Collaborative Leadership- Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment. High tolerance for ambiguity and able to create order from chaos. Builds credibility through solid relationships and solid track record of results.

Ownership and Accountability– Takes accountability for actions, drives results, and able to learn from mistakes. Delivers on promises, goals, and expectations. Makes quality decisions and resolves problems with minimal delay as appropriate. Asks “what can I do to help?”


Communication- Ability to communicate effectively up and down, at all levels of the organization, present complex and/or new ideas with clarity and simplicity. Ability to draft and deliver clear and concise procedures or business process documents.


Planning - Excellent planning and prioritization skills with the ability to multitask and adapt. Able to synthesize large amounts of information. Able to deliver results despite shifting environment.

Analytical Problem Solving– Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes. Innovative and effective in solution development, risk mitigation, and execution.
Customer focus - Partners with customers, looks ahead to predict future customer needs. Manages expectations.

Required Skills

Minimum 4 years of experience in a Quality/Compliance/Regulatory setting
Sound knowledge of cGMPs and equivalent industry regulations
Prior experience with technical oversight of Deviations and CAPAs
Proficiency with computer systems – Microsoft Office Suite
Proficiency with database use for example Veeva or other QMS, Benchling or other ELN, LIMS, Oracle or other ERP preferred

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.