Pharma Quality Complaint Lead (Product Safety & QA)

LNK International, Inc.; Town of Smithtown (NY); Vor Ort; USD 110.000 - 150.000; Vollzeit

Benefits dieser Stelle

Health insurance

401(k)

Zusammenfassung

LNK International, Inc. is seeking an experienced Quality Assurance Product Complaint Manager to join our fast-paced team in Hauppauge, Long Island.

The role supports compliant intake, investigation, and closure of product complaints for commercial OTC products to ensure patient safety and regulatory compliance. The candidate will manage investigations, coordinate sample testing, and draft responses, all while maintaining inspection-ready records and collaborating with cross-functional

Qualifikationen

• 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.
• 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.

Aufgaben

• 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.

Kenntnisse

Product complaints

Investigations

Quality systems

Regulatory compliance

cGMP knowledge

Communication skills

Microsoft Office

Detail-oriented

Ausbildung

Bachelor's degree in related field

Tools

Microsoft Word

Microsoft Excel

Jobbeschreibung

LNK International, Inc. is seeking an experienced Quality Assurance Product Complaint Manager to join our fast-paced team in Hauppauge, Long Island.

The role supports compliant intake, investigation, and closure of product complaints for commercial OTC products to ensure patient safety and regulatory compliance. The candidate will manage investigations, coordinate sample testing, and draft responses, all while maintaining inspection-ready records and collaborating with cross-functional