Quality Complaint Writer Jobs (NOW HIRING)

New Jersey, US; Cambridge, US; Gaithersburg, US   |   full time   |   Job ID: 11629 

About the Role:

As a Manager in Global Quality Intelligence & Product Quality Complaints, you will be responsible for establishing, implementing, and continuously improving a comprehensive Global Quality Assurance oversight framework to ensure robust GMP compliance for Marketing Authorization Holder (MAH) and Sponsor related activities across the global pharmaceutical footprint. You will drive the oversight, execution, and continuous improvement of the end-to-end complaint handling process for both clinical trial materials and commercial pharmaceutical products, and serves as a critical interface between Quality Assurance, Manufacturing, Supply Chain, Regulatory Affairs, Pharmacovigilance, Clinical and Commercial Operations, and external partners to ensure patient safety, product quality, and regulatory compliance.

Your Contribution:

• Ensure regional and global compliance in the capacity of an MAH/Sponsor representative by addressing evolving global regulatory expectations.
• Contribute to the development and maintenance of procedures, training, and quality oversight processes supporting product lifecycle, regulatory surveillance, recalls, and related MAH/Sponsor responsibilities.
• Build and maintain processes (e.g. Product Specification Files (PSFs)) ensuring compliance with productrelevant regulatory documentation (BLAs, MAAs, IMPDs, etc).
• Manage the end-to-end lifecycle of Product Quality Complaints (PQC) for clinical trial materials and commercial pharmaceutical products, ensuring effective intake, triage, assessment, investigation, classification, disposition, and closure.
• Ensure compliance with global regulatory requirements, internal procedures, and reporting obligations related to complaint handling.
• Lead complaint investigations and CAPAs, oversee third-party activities, and drive the timely escalation of quality and compliance risks.
• Serve as the primary point of contact for PQC-related activities, fostering effective collaboration across Quality, Pharmacovigilance, Medical Information, Release Hub, Supply Chain, and external partners.
• Support and represent the organization during inspections and audits related to MAH/Sponsor oversight and complaint handling, providing expertise, coordinating responses, and ensuring timely resolution of observations.
• Provide regular updates to leadership on quality metrics, compliance risks, escalations, and key achievements to support informed decision-making.
• Contribute to the standardization, globalization, digitalization, and continuous improvement of the BioNTech Quality Management System and associated processes.
• Act as a mentor and role model, promoting a culture of quality, compliance, accountability, and continuous improvement.
• Perform additional duties and responsibilities as required to support departmental and business objectives

A Good Match:

• Degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Extensive experience (5+ years) in Quality MAH/Sponsor responsibilities
• Proven track record of Product Quality Complaint Management, GMP compliance, and regulatory processes within the pharmaceutical industry.
• Strong knowledge of GMP guidelines, ICH Q10, CFR Part 211 and regional/national regulatory requirements.
• Exceptional communication and networking skills to foster collaboration across teams and stakeholders.
• Excellent written and verbal communication skills in English.
• Proven track record of critical thinking and agility. This includes the ability to manage priorities, track progress of key projects, and provide updates to leadership, as required.

Your benefits and remuneration:

Expected Pay Range: $113,600/year to $181,600/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

...and more! More details to be shared.
 

Located in the BioHealth Capital Region near Washington DC and ranked among the top biopharma hubs in the country, Gaithersburg, Maryland offers a unique and diverse cluster across industry, government, and academia for top talent and scientific innovation. As a pivotal player within the life sciences community, Gaithersburg is distinguished by its robust infrastructure and strategic location near the nation's capital. The city's strategic significance is amplified by its state-of-the-art manufacturing facilities that cater to the rigorous demands of the life sciences industry; Gaithersburg's manufacturing sector is defined by advanced technologies and complies with the most stringent regulatory standards, ensuring the production of high-quality pharmaceuticals, biologics, and medical devices. In the coming years, Gaithersburg will continue to be a vital contributor to the future of medical science and technology.

Apply now - We look forward to your application!

Apply for our New Jersey, US; Cambridge, US; Gaithersburg, US location and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider 'HireRight'. You will be informed accordingly by your BioNTech-Recruiter.