Director, Product Quality Leader

BioMarin Pharmaceutical Inc.

. Serve as a technical quality expert for one or more products during clinical development through post-commercialization .

Posted 9/30/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in technical quality leadership within the Biotechnology and Pharmaceutical industries, with a strong focus on regulatory compliance, risk management, and cross-functional collaboration. Proficient in developing quality strategies and managing product lifecycle quality considerations.

Highest-signal resume keywords

Technical Quality LeadershipRegulatory Compliance (21 CFR, USP, EP, JP, ICH)Biologics Product DevelopmentCross-Functional CollaborationRisk Management

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Quality Strategy DevelopmentProduct Specifications DevelopmentRegulatory Submission ReviewCGMP Principles ApplicationProduct Comparability ProtocolsAnalytical MethodsClinical and Commercial Product Lifecycle ManagementQuality Risk Register ManagementHealth Authority Commitments OversightCombination Products Quality Considerations

Soft Skills

Interpersonal SkillsCommunication SkillsLeadership CapabilityProblem SolvingPublic Speaking

Industry Keywords

BiotechnologyPharmaceuticalMedical DeviceHighly Regulated IndustryQuality AssuranceComplianceClinical DevelopmentPost-CommercializationCross-Portfolio InitiativesStakeholder Engagement

About the role

Key responsibilities & impact

Serve as a technical quality expert for one or more products during clinical development through post-commercialization
Make technical quality-related decisions and serve as the CMC team’s single point of contact for quality functions, risks and issues
Provide quality leadership for CMC-related strategic activities and drive quality decisions
Participate in CMC team meetings and technical forums, providing expertise for global strategies and implementation plans across the product lifecycle
Partner with CMC and Quality teams to identify, develop and prioritize long-term product strategies and initiatives
Create product-specific Quality strategies
Lead the cross-functional Quality Partner Team and manage deliverables aligned with CMC execution plans
Communicate relevant information between the Quality Partner Team, CMC Team and functional managers
Own and manage the product quality risk register, including issue identification, resolution, mitigation and escalation
Develop phase-appropriate product specifications and collaborate on the Quality Target Product Profile and product control strategy
Develop product comparability protocols and assessments for clinical-stage and commercial products
Interpret and apply regulatory guidelines and directives including 21 CFR, USP, EP, JP and ICH
Review and author regulatory submission sections
Review and approve Annual Product Reviews for commercial programs
Oversee and monitor CMC-related Health Authority commitments
Support or lead initiatives to improve PQL operational efficiency and effectiveness
Lead cross-portfolio initiatives to reduce technical quality risks

Requirements

What you’ll need

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 biologics product development and licensure or technical support
Experience in both clinical and commercial phases of product lifecycle is highly desirable
Experience supporting combination products across clinical and commercial stages, including device quality considerations, is a plus
Excellent interpersonal and communications skills
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
Experience developing relationships focused on best-practice sharing and collaborative problem solving
Ability to work with ambiguity and complexity and 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 knowledge and experience in Quality with biologic and chemical processes, drug development, and analytical methods
Prior experience with Regulatory, Quality, Compliance or a combination of technical experience such as analytical development, manufacturing sciences and Quality/Regulatory
Periodic travel is required

Benefits

Comp & perks

Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer
Periodic travel is required