QA Product Complaint Manager

Join a Leader in the OTC Industry!  

LNK International - a leading OTC pharmaceutical manufacturer located in Hauppauge, Long Island, NY, seeks an experienced Quality Assurance Product Complaint Manager to join our fast-paced team.

This position reports to the Director, Quality Assurance and is part of the Quality department which is responsible for ensuring compliant management of product complaints associated with commercial OTC products. The role is responsible for the intake, assessment, investigation, documentation, and closure of product complaints in accordance with applicable regulatory requirements and company procedures and works closely with Manufacturing, Packaging, QC Laboratory, Quality Assurance, and external partners to support product quality, patient safety, and regulatory compliance.

We are looking for a candidate who will be a long-term team member and become an integral part of a strong technical team.

Minimum Education or Experience Required:

• Bachelor's degree in a related field required.
• Solid experience with product complaints, investigations, quality systems, and regulatory compliance activities required.
• Working knowledge of cGMP requirements and quality management systems required.
• Minimum 4 years of relevant experience in biotech or pharmaceutical industry, bachelor's degree or equivalent years of work experience.
• Minimum 3 years of experience managing pharmaceutical product complaint processes. Excellent verbal and written communication skills, a must.
• Strong knowledge of FDA, global GMP, pharmacovigilance, and product complaint regulations and guidance.
• Strong written and verbal communication skills, with the ability to communicate effectively across all levels of the organization
• Computer experience is a must. Broad knowledge of Microsoft Office including Word and Excel.
• Highly organized and detail-oriented individual.

Areas of Responsibility:

• Manage the department to ensure the intake, assessment, documentation, investigation, and closure of product complaints for commercial products are in accordance with applicable regulations and company procedures.
• Receive, evaluate, and process product complaints, including identification and forwarding of potential adverse event, lack-of-effect, and product quality reports to appropriate functions.
• Conduct and coordinate complaint investigations with internal and external stakeholders to obtain information necessary to support complaint evaluations and product quality assessments.
• Ensure complaint records are complete, accurate, well-written, fact-based, and maintained in a state of inspection readiness.
• Manage follow-up activities with consumers, healthcare professionals, pharmacies, distributors, and other external contacts as necessary to obtain complaint information and supporting documentation.
• Coordinate product sample return activities, sample tracking, laboratory testing requests, and related complaint documentation.
• Draft and issue complaint response communications as required.
• Maintain compliance with cGMP requirements, regulatory expectations, and internal quality procedures.
• Review and approve product complaint records, investigations, assessments, customer communications, and closure documentation to ensure completeness, accuracy, compliance, and adherence to company procedures.
• Exercise independent judgment in evaluating complaint information, determining investigation requirements, assessing product quality impact, and recommending appropriate disposition and closure activities.
• Ensure company SOPs are adequate and meet GMP standards. This may include the approval and creation of SOPs.
• Also responsible for noting trends and informing appropriate personnel for corrective action.
• Assist the Director of Quality in the implementation and monitoring of the quality system.
• Responsible for complaint investigations and Adverse Event Reporting for Consumer Complaints. as per SOP.
• Oversee the management of the complaint system database and complaint files.
• Responsible for overseeing/performing other duties within the quality organization as required. Specific responsibilities may include, but are not limited to:
  • Ensuring that ANDA complaint documentation is collected and provided for periodic submissions.
  • Ensuring all complaints are completed and communicated to the consumer accordingly.
  • Participates in internal, external, and regulatory audits.
  • Providing statistics relevant to department.

LNK provides competitive compensation and a full benefits package, including health and dental insurance and 401(k). Please forward your resume in confidence for immediate consideration.

The salary listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining a team member's base salary and/or rate, several factors may be considered as permitted by law.

LNK provides equal employment opportunities to all applicants and prohibits discrimination of any type on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information or any other characteristic protected by applicable federal, state or local laws.

EOE M/F/D/V