Product Quality LeaderLocation Novato, California
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 Product Quality Leader is responsible for the product quality lifecycle as well as global activities for clinical and commercial products, creating and managing a strategy that aligns with business drivers. The PQL represents Quality on the CMC team, the Technical Development Team (TDT) and are the single point of contact for the product. The PQL leads a Product Quality PartnerTeam, which is dotted line, to generate a product quality risk log so that weak signals are captured and full awareness of the risks are escalated appropriately.
This position required a broad range of knowledge and experience with biologic and chemical processes, drug development, analytical testing methods and understanding of the international regulatory landscape.
The incumbent must possess technical expertise in the areas of responsibility and demonstrate technical and personnel leadership qualities.
KEY RESPONSIBILITIES - Technical
- Develop and drive an end-to-end product quality lifecycle from clinical to commercial scope, in alignment with commercial business drivers and process development capabilities.
- Provide quality perspective and expertise while representing Quality on the CMC team, the TDT and other product teams as the single decision maker.
- Drive global solutions in order to maintain a continuous supply to patients.
- Identify key product quality risks and bring full awareness of the risks, including weak signals and potential blind spots.
- Interpret and apply applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives
- Accountable to lead the Product Quality Partner Team to identify and resolve issues, and to identify and escalate potential multi-product risks and issues.
- Provide technical expertise and leadership as required, and provide recommendations and influence to global issues.
- Support product regulatory filings by driving clarity and consistency with specifications and CQAs.
- Support product transition from clinical to commercial, new product introductions and tech transfers across the network.
- Ensure alignment of product changes and collaborate with key colleagues to develop bundling strategies that maintain supply while improving product robustness.
- Define and monitor product quality health metrics, including review and approval of APR.
KEY RESPONSIBILITIES - Leadership
- 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 with minimal resources.
- Consistent demonstration of managerial courage to make timely decisions without complete data to ensure quality product to patients.
- Consistently demonstrates sound quality judgement and balances between business, supply and quality aspects.
- Ability to influence decision makers and utilizes sound problem solving skills to recommend options and implement effective solutions.
- 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.
This is a new position with three levels of expertise
BS/MS/B.Sc/M.Sc./PhD preferably in the life sciences or engineering.
QP certification or equivalent preferred.
- 6+ years’ experience in pharmaceutical or related industry
- 4+ years of previous people management indirect team leadership.
- Demonstrated knowledge of cGMPs, Health Authority Regulations, Quality Systems and technical expertise in DS/DP/FG manufacturing processes. Knowledge of devices, combination products and device development desirable.
- International/global experience preferred
- Proven leadership skills Organizational and management skills to coordinate multi-discipline project groups
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for process validation expectations.
This position will interact with all other departments throughout the organization. This position will partner and influence with Regulatory Affairs, Compliance, Process Development, Finance, WWRD, and other departments as required. This position requires constant contact with Senior management across the organization.
MANAGER RESPONSIBILITYManage a Product Quality Partner Team that is dotted line – typically 8-10 people.
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.