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.

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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.

\nHow Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

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