Product Quality Associate Director

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

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

• Collaborate with departments such as Product Quality, International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance, and others.

• Assist with product filings, program enhancements, and investigations related to product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, import testing, change control, regulatory submissions, and inspections.

• Act as the accountable Product Quality Leader representing Quality on Product Delivery Teams for late-stage or commercial biologics products.

• Create, implement, and oversee strategies to achieve Product Delivery Team objectives.

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

• Perform transactions in pertinent GMP systems.

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

• Specify Product Quality deliverables and timelines across Product Delivery Teams.

• Facilitate discussions and lead decision-making for Product Quality strategies and initiatives.

• Direct actions across Product Quality teams and cross-functional subject matter experts.

• Offer cross-functional Quality leadership and influence program deliverables for late-phase and commercial initiatives.

• Assist with annual product reviews, specifications, comparability and stability programs, site and method transfers, and product quality impact assessments.

• Draft Product Quality-owned sections for regulatory filings and responses to inquiries.

• Provide subject matter expertise and strategic guidance for science- and risk-based evaluations of intricate process and product quality data.

• Formulate patient-focused strategies that address business needs and deliver innovative solutions to complex challenges.

⛳️ Requirements

• Doctorate degree with 3 years of experience in Quality, Operations, Scientific, or Manufacturing OR Master’s degree with 5 years OR Bachelor’s degree with 7 years OR Associate’s degree with 12 years OR High school diploma / GED with 14 years in Quality, Operations, Scientific, or Manufacturing.

• Preferred: B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field.

• Experience with escalating responsibility in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing settings is preferred.

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

• A minimum of 1 year of experience in authoring or reviewing market applications, INDs, supplements, or comparable regulatory documentation is preferred.

• Proficient in articulating complex information effectively to Product Quality leadership, peers, and regulatory bodies, both orally and in writing.

• Familiarity with cGMP and international regulatory standards.

• Strong skills in scientific data management and organization, with meticulous attention to detail.

• Capable analytical and problem-solving skills.

• Ability to collaborate efficiently with global, virtual teams.

• High levels of initiative and self-motivation.

• Competence in managing multiple priorities, responding swiftly to urgent demands, and meeting tight deadlines.

• Team-oriented, focused on achieving collective goals.

• Sponsorship for this position is not guaranteed.

🏝️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous contributions from the company.

• Group medical, dental, and vision insurance coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work arrangements where feasible.

• Opportunities for career development.

• Support for work/life balance.