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Director, Group Lead - Product Quality Leaders (PQLs)

Employer
BioMarin Pharmaceutical Inc.
Location
Novato, California
Start date
Aug 2, 2021

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Job Details

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. 

SUMMARY

The PQL group is comprised of Product Quality Leaders (PQLs)/Technical Product Leaders (TPLs) and CMC Module 3 Data Accuracy Management (M3DAC). The Group Lead will lead a team of PQLs and will report directly to the Head of the PQL Group.

The Group Lead is accountable for leading, developing and managing a group of high performing Product Quality Leaders (PQLs) to maintain and improve product quality for clinical and commercial products for selected modalities such as Oligosaccharide, Small Molecules and ERT programs. The Group Lead can also be a Technical Product Lead (TPL) and/or Product Quality Leader as needed.

This role will interact and partner with key cross-functional stakeholders within and outside of TOPs to look for synergies and efficiencies in processes and systems.

This position requires a high level of influencing, collaboration, and communication skills as well as a broad range of knowledge and experience in quality with biologic and chemical processes, drug development and analytical methods. Understanding of the international regulatory landscape is preferred.

Key Responsibilities

  • Lead and develop a team of PQLs.
  • Develop and mature the PQL role by implementing refinements to the role, processes, and tools. Collaborate with cross-functional team to refine and mature the Quality Partner Team (QPT).
  • Develop and maintain a balanced training and development plan for the PQL role to meet the evolving product pipeline.
  • Provide strategic guidance, technical expertise and leadership as required and provide recommendations and influence on global issues.
  • Proven leader with demonstrated ability to build and lead successful cross functional teams
  • Strong collaboration skills and demonstrated ability to lead change and identify opportunities that have resulted in positive business outcomes
  • Excellent organizational agility that demonstrates how to get results while strengthening internal and external relationships
  • Consistent demonstration of managerial courage to make timely decisions without complete data to ensure quality product to patients
  • Ability to influence decision makers and utilizes sound problem-solving skills to recommend options and implement effective solutions
  • Consistently demonstrates sound quality judgement and balances between business, supply and quality aspects.
  • Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.
  • Demonstrated ability for highly developed ability to communicate in both oral and written domains.
  • Proven ability to translate complex scientific or quality concepts across all levels of understanding.
  • Attend and participate fully in CMC team meetings, and other relevant technical forums, to provide technical quality expertise to influence global strategies and ensure robust implementation plans for product/program changes
  • Identify and lead cross portfolio initiatives or improvements that will reduce overall risks as required

EXPERIENCE

  • 12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry
  • 5+ years of prior management level experience with demonstrated ability to develop and mentor staff
  • Excellent interpersonal and communications skill
  • Ability to influence diverse stakeholder and drive accountability and decision-making cross-functionally
  • Ability to work effectively with stakeholders and PQLs in various countries/regions
  • Demonstrated ability to partner with other functional groups to achieve business objectives
  • Results oriented; effectively manages multiple projects efficiently
  • Excellent written and verbal skills; ability to communicate effectively with all levels of the organization; effective public speaker
  • Builds strong, effective working teams; builds relationships to share best practices, and collaboratively solve problems
  • In-depth understanding and application of cGMP principles, concepts, practices and standards
  • Prior experience with Regulatory, Quality, Compliance or a combination of technical experience such as analytical development/manufacturing sciences and Quality/Regulatory
  • Broad range of knowledge and experience in Quality with biologic and chemical processes, drug development, analytical methods and understanding of the international regulatory landscape preferred
  • Understanding and familiarity with FDA & European regulatory requirements, and guidelines

EDUCATION

  • BA/BS in life sciences or related field
  • Advanced degree desirable, but not required
  • Other continuing education initiatives or relevant industry or compliance certifications


OTHER

Ability to travel up to 30% as required

 

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.

Company

BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

Company info
Website
Location
California
United States

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