Director, Product Quality Leader

Lyten; United States; Remote; USD 164,000 - 226,000; Full time

Job summary

Join a forward-thinking company at the forefront of biotechnology, where your expertise in quality assurance and product lifecycle management will drive innovation. This role offers the chance to influence global strategies and ensure the highest quality standards for transformative medicines. Collaborate with a dynamic team, navigate complex regulatory landscapes, and lead initiatives that enhance operational efficiency. With a competitive salary and comprehensive benefits, this is an opportunity to make a meaningful impact in the world of healthcare.

Benefits

Discretionary Annual Bonus

Stock-Based Long-Term Incentives

Paid Time Off

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Qualifications

• 12+ years in Biotechnology or Pharmaceutical industries.
• Experience in gene therapy or biologics product development.

Responsibilities

• Lead product quality risk management and CMC team communications.
• Develop product specifications and quality strategies.

Skills

Leadership Skills

Interpersonal Communication

Regulatory Knowledge

Project Management

Quality Assurance

Education

BA/BS in Life Sciences

Advanced Degree

Tools

cGMP Principles

Analytical Methods

Job description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Technical Operations

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.

Role Overview

This individual will serve as a technical quality expert for one or more products during clinical development all the way through post-commercialization. The role is responsible for making technical quality-related decisions and serving as the single point of contact on the CMC (Chemistry, Manufacturing and Controls) team for all quality functions, risks and issues associated with the assigned products. As a core member of the CMC team, the PQL provides efficient and effective quality leadership of CMC-related strategic activities and drives associated quality decisions.

Key Responsibilities

• As the single point of contact within a CMC Team for all product quality topics, participate fully in CMC team meetings, and other relevant technical forums, providing technical quality expertise to influence global strategies and ensure robust implementation plans for product/program changes for all stages of the product life cycle (Pre-IND through post-Launch lifecycle management)
• Partner with CMC Team and the Quality organization to identify, develop and prioritize long-term product strategies/initiatives enabling the clinical to commercial transition, new product introductions and tech transfers; accountable for creation of the product-specific Quality strategy
• Lead the cross-functional Quality Partner Team (QPT) supporting Quality-related CMC deliverables; accountable for managing the QPT deliverables in alignment with CMC execution plans, including timelines and scope. Responsible for timely and clear communication of all relevant information to and from the QPT to the CMC Team and functional managers
• Own and manage the product quality risk register to ensure identification, resolution, mitigation and/or escalation of product quality issues and risks to CMC team and/or Senior Management
• Responsible for developing a phase appropriate product specification as part of product control strategy creation; collaborate with CMC Lead to establish a phase appropriate Quality Target Product Profile (QTPP) and ensure the right quality characteristics are implemented during product development.
• Lead efforts to develop product comparability assessments for clinical-stage and commercial products, including sample selection and acceptance criteria identification needed to support process/site changes
• Interpret and apply applicable regulatory guidelines and directives (e.g., 21CFR, USP, EP. JP, and ICH) to product quality, staying abreast of changes and advising stakeholders appropriately
• Review and author regulatory submissions sections and provide input to ensure clarity and consistency of messaging across Quality owned sections
• Responsible for the review and approval of Annual Product Review for represented commercial programs
• Provide oversight and monitor CMC related Health Authority commitments and ensure timely completion. Provide routine updates and visibility of submission commitments to functional and senior management
• Support, or lead, efforts to identify, define, and mobilize initiatives to improve the efficiency and effectiveness of PQL operational processes
• Identify and lead cross portfolio initiatives or improvements that will reduce overall technical quality risks for the product portfolio, as required

Experience/Education

• BA/BS in life sciences or related field required. Advanced degree desirable.

• 12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry; preferred experience in gene therapy or biologics product development and licensure or technical support; experience in both clinical and commercial phases of product lifecycle a plus.
• Excellent interpersonal and communications skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization

• Demonstrated strong leadership capability with ability to align on, make and act on decisions while balancing speed, quality, and risk

• Experience with influencing diverse stakeholders and driving accountability and decision-making in a highly matrixed, cross-functional environment
• Highly capable of building strong, effective working teams; experience with developing relationships focused on best-practice sharing and collaborative problem solving
• Skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization
• 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
• In-depth understanding and application of cGMP principles, concepts, practices and standards; understanding of the international regulatory landscape preferred
• Broad range of knowledge and experience in Quality with biologic and chemical processes, drug development, analytical methods
• Prior experience with Regulatory, Quality, Compliance or a combination of technical experience such as analytical development, manufacturing sciences and Quality/Regulatory

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disabilit y.
The salary range for this position is: $164,000 to $225,500. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

For additional benefits information, visit: https://careers.biomarin.com/benefits .

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.