Manager, Global Quality Intelligence & Product Quality Complaints

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, Global Quality Intelligence & Product Quality Complaints based in United States.

This role offers the opportunity to shape global quality assurance oversight across a complex pharmaceutical <organization.You> will help ensure strong GMP compliance for Marketing Authorization Holder and Sponsor responsibilities across the product lifecycle.A key focus will be leading the end-to-end management of product quality complaints spanning both clinical trial materials and commercial <products.You> will work across Quality, Manufacturing, Supply Chain, Regulatory Affairs, Pharmacovigilance, Clinical, Commercial Operations, and external partners.The position combines operational ownership, regulatory expertise, risk management, and continuous process <improvement.You> will also contribute to inspections, audits, CAPAs, quality systems, and the standardization and digitalization of global processes.This is an impactful opportunity for a quality professional who wants to strengthen patient safety, product quality, and regulatory compliance at global scale.

Accountabilities

Global quality oversight: Establish, implement, and continuously improve a comprehensive quality assurance oversight framework supporting Marketing Authorization Holder and Sponsor activities across global pharmaceutical operations.

Regulatory compliance: Ensure regional and global compliance with evolving regulatory expectations and maintain appropriate oversight of MAH/Sponsor responsibilities throughout the product lifecycle.

Quality documentation: Develop and maintain procedures, training, and quality oversight processes, including Product Specification Files and documentation supporting regulatory submissions and product requirements.

Product quality complaints: Own the end-to-end lifecycle of product quality complaints for clinical trial materials and commercial products, covering intake, triage, assessment, investigation, classification, disposition, and closure.

Investigations and CAPAs: Lead complaint investigations, oversee corrective and preventive actions, manage third-party activities, and ensure timely escalation and resolution of quality and compliance risks.

Cross-functional collaboration: Serve as a key point of contact for complaint-related activities, partnering closely with Quality, Pharmacovigilance, Medical Information, Release, Supply Chain, and external stakeholders.

Audits and inspections: Support and represent the organization during regulatory inspections and audits involving MAH/Sponsor oversight and complaint handling, coordinating responses and driving timely closure of observations.

Quality intelligence and reporting: Provide leadership with regular updates on quality metrics, compliance risks, escalations, trends, and achievements to enable informed decision-making.

Quality system improvement: Contribute to the standardization, globalization, digitalization, and continuous improvement of the Quality Management System and associated processes.

Culture and leadership: Act as a mentor and role model, promoting accountability, quality excellence, regulatory compliance, collaboration, and continuous improvement across the organization.

Requirements

Education: Bachelor's degree or equivalent in Pharmacy, Chemistry, Biology, or another relevant scientific discipline.

Industry experience: 5+ years of experience with Quality Marketing Authorization Holder or Sponsor responsibilities within the pharmaceutical industry.

Complaint management: Demonstrated experience managing Product Quality Complaints, including investigation, classification, escalation, CAPA, and regulatory requirements.

GMP expertise: Strong understanding of GMP requirements, ICH Q10, CFR Part 211, and applicable regional and national regulatory expectations.

Regulatory knowledge: Experience working with pharmaceutical quality systems, regulatory processes, lifecycle activities, and MAH/Sponsor obligations.

Quality systems: Familiarity with quality oversight procedures, product documentation, regulatory surveillance, recalls, and related compliance processes.

Cross-functional influence: Strong communication, collaboration, and networking skills, with the ability to build effective relationships across diverse functions and external partners.

Communication: Excellent written and verbal English communication skills, with the ability to present quality information clearly to both technical and senior leadership audiences.

Analytical thinking: Strong critical-thinking, problem-solving, and decision-making abilities, particularly when assessing quality risks and complex investigations.

Prioritization: Ability to manage multiple priorities, track key projects and commitments, identify risks, and provide clear progress updates to leadership.

Leadership mindset: Demonstrated ability to mentor others and promote a culture of quality, compliance, accountability, and continuous improvement.

Adaptability: Comfortable operating in a complex, highly regulated environment and responding effectively to evolving business and regulatory requirements.

Benefits

Competitive compensation: Expected annual pay range of $113,600–$181,600, with actual compensation based on responsibilities, education, experience, knowledge, skills, and abilities.

Additional compensation: Eligibility for annual bonus and equity, with variable components dependent on individual and organizational performance.

Healthcare: Medical, dental, and vision insurance.

Financial protection: Life, AD&D, and critical illness insurance.

Pre-tax programs: HSA, FSA, and dependent care reimbursement accounts.

Family support: Parental and childbirth leave, family planning assistance, and childcare and tutoring support.

Time off: Vacation, sick leave, bereavement leave, holidays, floating holidays, and year-end U.S. shutdown.

Retirement: 401(k) plan with company matching.

Wellbeing: Employee assistance and concierge services available 24/7, wellbeing programs, and associated incentives.

Professional development: Tuition reimbursement, student loan assistance, and professional development programs.

Commuting support: Commuting allowance and subsidized parking.

Insurance discounts: Discounted home, auto, and pet insurance.

Work locations: Opportunity to work from locations including New Jersey, Cambridge, Massachusetts, and Gaithersburg, Maryland.