Product Quality Associate Director

About This Opportunity

Our talent team at Get A Job.ai is representing a confidential biopharmaceutical organization seeking a Product Quality Associate Director. This is a strategic quality leadership role where you'll provide technical expertise and oversight for late-stage and commercial product portfolios. You'll serve as the accountable quality leader on cross-functional product delivery teams, engaging with regulatory, manufacturing, process development, and quality assurance stakeholders on critical activities ranging from regulatory submissions to product stability programs.

Responsibilities

• Define and deliver Product Quality objectives within established timelines across cross-functional product delivery teams, ensuring priorities align with program guidance
• Lead strategic decision-making and coordinate activities within Product Quality teams including quality assurance, stability, process development, and related functions
• Provide cross-functional quality leadership for late-phase and commercial programs, supporting annual product reviews, specifications development, comparability assessments, and stability programs
• Author and review GMP and regulatory documents, execute transactions in GMP systems, and manage product data including risk assessments
• Conduct science and risk-based evaluations of complex process and product quality data, developing patient-oriented strategies that balance business needs with regulatory requirements
• Support site and method transfers, product quality impact assessments, and regulatory filing sections
• Lead investigations related to product manufacturing, in-process controls, analytical methods, specifications, and reference standards
• Represent Quality on regulatory inspections and provide subject matter expertise to influence product health initiatives

What We're Looking For

Minimum Qualifications (one of the following):

• Doctorate degree and 3 years of Quality, Operations, Scientific, or Manufacturing experience
• Master's degree and 5 years of relevant experience
• Bachelor's degree and 7 years of relevant experience
• Associate's degree and 12 years of relevant experience
• High school diploma/GED and 14 years of relevant experience

Preferred Qualifications:

• Bachelor's or advanced degree in chemistry, biochemistry, biology, or related pharmaceutical sciences field
• 6+ years working in a regulated GMP environment with biologics product experience
• 1+ years experience authoring or reviewing market applications, INDs, supplements, or similar regulatory documentation
• Proficiency in oral and written communication of complex information to leadership, peers, and regulatory agencies
• Strong knowledge of cGMP and international regulatory expectations
• Excellent scientific data management and organizational skills with attention to detail
• Analytical and problem-solving capabilities
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Proven ability to manage multiple priorities and meet challenging timelines
• Team-oriented mindset focused on achieving collective goals

How We Work With You

When you apply through Get A Job.ai, one of our experienced recruiters will review your qualifications and conduct an initial screening. If there's a strong match, we'll submit your profile to our client for consideration. Throughout the process, we'll serve as your advocate and main point of contact. Please do not contact the client directly—all communication should flow through our team to ensure the best outcome for your candidacy.

Pay

Compensation details will be discussed during the screening process based on your experience and qualifications.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive hiring practices and considers all qualified candidates regardless of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or any other protected characteristic.