Manager, Quality and Continuous Improvement

Location:  Novato, California Category: Manufacturing

Description

Who We Are

For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease.  In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.

And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.

Our Culture

Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.

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.

Summary
Build on the OE plan that has been developed across Technical Operations, work with key stakeholders within Quality to deploy an effective lean management system over the next three years in the US region.

The role will report into the BPI organization and oversee both global and site Quality programs.


RESPONSIBILITIES

  • Co-design, support or directly deploy the key elements of the daily management system (DMS) into quality at both Novato and Global quality. These include but are not limited to: visual factory, standard work, 5S and leaders standard work.
  • Be available to support acute business challenges within quality as they arise.
  • Lead improvement kaizens or projects within Quality that will increase its performance or create capacity.
  • Work with OE partners globally to help solicit support where required for problems that require specialist technical lean six sigma or other analogous support.
  • Work with stakeholders at all levels to deepen OE capabilities within BioMarin.

 

Competencies:

  • Cognitive capability – Ability to learn quickly and to be able to share those learnings to wider colleagues in a way that is understandable.
  • 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?”
  • 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.
  • 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/Organization - 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.

 

EDUCATION

  • Science or Engineering background required, ideally with some Business background preferred but not essential.
  • Formal Lean training/qualifications preferred.
  • Having a background in Quality is preferred but not essential.

EXPERIENCE

  • Must have extensive experience in driving lean to a high standard.
  • Must have a demonstrated track record in driving performance through self and others by inventively harnessing surrounding (albeit often) constrained resources.
  • Minimum 5 years of experience in industry with some in biopharma.
  • Sound knowledge of cGMPs and equivalent industry regulations.


Position is based in Novato, CA.  Hybrid workstyle requiring 2-3 days per week onsite in Novato.  To support the business most effectively, travel may be required up to 10% of the time.


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.