Principal Product Quality Leader

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver technical expertise and leadership within a Product Quality Team.

• Collaborate with Product Quality, International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance, and various other departments.

• Provide support for late-stage or commercial biologics products.

• Create, execute, and oversee strategies to achieve the objectives of the Product Development Team.

• Author, own, and review GMP and regulatory documents.

• Conduct transactions in relevant GMP systems.

• Manage product data, which includes comparability assessments, annual product reviews, and product quality risk assessments.

• Offer cross-functional quality leadership and support program deliverables for late-phase and commercial initiatives.

• Assist with annual product reviews, specifications, comparability and stability programs, site and method transfers, product quality impact assessments, PQ-owned regulatory filing sections, and RTQs.

• Perform scientific and risk-based evaluations of complex process and product quality data.

• Develop patient-focused strategies that consider business needs and provide innovative solutions to intricate issues.

• Work collaboratively at the intersection of research, global development, and manufacturing to facilitate the development of medications.

⛳️ Requirements

• Doctorate degree with 2 years of experience in Quality, Operations, Scientific, or Manufacturing, or a Master’s degree with 4 years of such experience, or a Bachelor’s degree with 6 years of such experience, or an Associate's degree with 10 years of such experience, or a High School Diploma/GED with 12 years of such experience.

• A B.S. or advanced degree in chemistry, biochemistry, biology, or a related field in pharmaceutical sciences is preferred.

• Experience with progressive responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing setting is preferred.

• 6+ years of experience in a regulated environment, particularly with biologic products, is preferred.

• At least 1 year of experience in authoring or reviewing market applications, IND, supplements, or similar regulatory documentation is preferred.

• Strong proficiency in communicating complex information effectively, both orally and in writing, to Product Quality leadership, peers, and regulatory bodies.

• Familiarity with cGMP and international regulatory standards.

• Excellent scientific data management and organizational skills, with a keen attention to detail.

• Strong analytical and problem-solving abilities.

• Capacity to work efficiently with global, virtual teams.

• A high degree of initiative and self-motivation.

• Ability to juggle multiple priorities, respond swiftly to urgent requests, and meet demanding timelines.

• A team-oriented approach focused on achieving collective goals.

• Sponsorship for this position is not guaranteed.

🏝️ Benefits

• Comprehensive employee benefits package.

• Retirement and Savings Plan featuring generous company contributions.

• Group medical, dental, and vision insurance.

• Life and disability coverage.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where applicable.

• Opportunities for career development.

• Support for work/life balance.

• Financial plans to help save for retirement or other objectives.