Senior Compliant Investigator, Post Market Compliance

Job Description

About Us:

Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide. 

Job Summary:

Are you ready to make an impact in the world of product quality and regulatory compliance? As the Senior Complaint Investigator in Post Market Compliance (PMC) at Aveva Drug Delivery Systems, you’ll be at the forefront of ensuring our products meet the highest standards of quality and safety. In this key role, you will manage and oversee the reporting and investigation of product quality complaints from consumers, marketing partners, and other sources.

This includes managing consumer, marketing partner, and other sources of product quality complaints or inquiries. The Senior PMC Investigator leads the scheduling and workflow of the PMC team, reviews and approves technical complaint cases, and provides training to PMC personnel. This role ensures that technical complaints comply with regulatory requirements, including those from the FDA, Health Canada, and other relevant regulatory bodies.

The Senior Complaint Investigator will also track and report complaint data to Aveva management (Quality Council), regulatory agencies, and partners. They will ensure timely investigation and documentation of customer complaints and maintain a validated customer complaint database in compliance with FDA regulations.

In addition, this position is responsible for compiling the Annual Product Reviews (APRs) for Aveva’s commercial products, ensuring timely submission of Executive Summaries and APRs within required timeframes. Join Aveva’s Post Market Compliance team and play a critical role in ensuring product quality, safety, and regulatory compliance!

Key Responsibilities:

• Manage the complaint handling reporting system, collaborating with management, partners, contractors, and regulatory agencies.
• Oversee the scheduling and allocation of PMC resources to ensure efficient initiation, investigation, reporting, and approval of customer complaints.
• Ensure that critical complaints with potential market impact follow the internal escalation process.
• Initiate, investigate, document, and manage customer complaints, including leading multidisciplinary investigations.
• Evaluate and approve complaint investigations, ensuring all requirements are met and investigations are completed in a timely manner.
• Provide timely support to investigators by identifying appropriate Subject Matter Experts, determining root causes, and developing corrective and preventative actions.
• Write procedures and reports, perform weekly and monthly exchanges, and ensure compliance with regulatory reporting requirements.
• Analyze data and report trends in quality systems to Aveva Drug Delivery Systems management through the Quality Council and Annual Product Reviews.
• Submit Periodic Reports, Annual Reports, and other regulatory submissions as assigned for Aveva-owned marketing applications.
• Participate in inspections by regulatory agencies and auditors, serving as the primary contact or inspection team coordinator when needed.
• Collaborate with team members to achieve all goals and ensure compliance with quality standards.
• Operate in alignment with Aveva Drug Delivery Systems Code of Conduct, Business Ethics, and all regulatory, compliance, and safety requirements.
• Uphold Aveva Drug Delivery Systems core values of Collaboration, Courage, Perseverance, and Passion.
• Perform any other duties as assigned.

Qualifications

Education:

• Minimum of a High School Diploma required.
• Bachelor’s Degree in Science, Mathematics, Technology, or Engineering is highly preferred.

Experience:

• A minimum of 5 years’ experience in Post Market Compliance or Quality Assurance experience with a pharmaceutical company required. 
• Strong background in managing customer complaint processes.
• Knowledge and experience with GCPs, GMPs, GLPs, and post-market safety and surveillance compliance.
• Proficiency in investigation processes and root cause analysis tools.

Knowledge, Skills, and Abilities:

• Knowledge of investigation processes and root cause analysis techniques.
• Strong ability to communicate effectively, both in person and in writing, with senior management and regulatory authorities.
• Ability to work independently with minimal supervision, using experience and good judgment to plan and accomplish goals.
• Skilled at managing multiple tasks simultaneously and adapting to changes in projects or business requirements.
• Ability to handle a variety of complex tasks and serve as a resource in resolving problems and issues.
• Excellent organizational skills and the ability to coordinate and prioritize work efficiently.
• Strong interpersonal skills, with the ability to interface effectively across different levels of an organization.
• Ability to adapt procedures, techniques, tools, materials, and equipment to meet specific needs.
• Proficient in a Windows environment, including the use of Microsoft Office Suite (Excel, Word, PowerPoint, Access), email, and internet.
• Familiarity with QMS/GMP software such as JDE, TrackWise
• Competency in writing clear and concise reports in English.
• Ability to delegate tasks, train, coach, and review the work of peers.

Physical Requirements:

• Ability to sit for extended periods, use hands for typing, handle tasks, and reach with hands and arms.
• Frequent need to talk and hear; occasional standing and walking.
• Must occasionally lift or move up to 10 pounds.
• Specific vision abilities, including depth perception and the ability to adjust focus.

Additional Skills (Desired):

• Knowledge of transdermal systems is a plus.

Benefits:

Aveva Drug Delivery Systems and DifGen Pharmaceuticals provides a comprehensive benefits plan

• Medical/Dental/Vision Insurance
• Paid Time Off
• 401k with employer match
• Paid Holidays and Floating Holiday

Equal Opportunity Employer

Salary : $25 - $33