GDP Operational QA, Senior Specialist - Veritas Search Group

GENERAL POSITION SUMMARY:
The Senior Quality Specialist role focuses on ensuring medicines are distributed across the United States in full compliance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) requirements. This position involves managing the day-to-day quality oversight of Third-Party Logistics (3PL) providers, working closely with internal stakeholders to ensure smooth distribution processes, and supporting key activities for the launch of new products.

KEY ACCOUNTABILITIES:

• Oversee the quality performance of distribution partners within the USA, which includes:
  • Preparing and maintaining Quality Agreements
  • Reviewing deviations, CAPA (Corrective and Preventive Actions), and changes
  • Monitoring and maintaining key performance indicators (KPIs)
  • Analyzing and addressing compliance issues and customer concerns
  • Escalating significant issues as needed
  • Managing the release of finished goods at 3PL facilities
• Stay informed of new GDP and logistics developments, ensuring that the Quality Management System (QMS) remains compliant with emerging regulations.
• Lead efforts related to new product launches by managing distribution requirements and setting clear expectations.
• Collaborate effectively with key internal teams and stakeholders to support clinical quality assurance in distribution.

KEY RESPONSIBILITIES:

• Maintain the Quality Management System (QMS) in alignment with current standards and requirements.
• Ensure that distribution licenses accurately reflect organizational changes, and make adjustments where necessary.
• Assist with product recalls, mock recalls, and other on-market activities.
• Act as the Quality Assurance (QA) assessor and approver on change controls, ensuring resolution of gaps, approval of plans, and strategic GDP/GMP actions.
• Support the GDP Management Review process by evaluating risks, identifying gaps, and recommending mitigation strategies.
• Participate in expansion initiatives, ensuring that Quality actions are integrated into project plans and completed according to commitments.
• Plan, prepare for, and support regulatory inspections, providing front and backroom inspection support, and handling post-inspection follow-up, including responses and CAPAs.
• Manage event investigations and fast-track deviations, ensuring thorough oversight and resolution.
• Oversee the management of CAPAs and effectiveness checks to ensure compliance and continuous improvement.

Additional responsibilities include:

• Collaborating with the product complaints team to ensure timely and effective resolution of customer complaints.

• Approving suppliers and subcontracting activities that may impact GDP.

• Conducting self-inspections at regular intervals and implementing corrective measures where necessary.

• Deciding on the disposition of returned, rejected, recalled, or counterfeit medicines, including the approval of returns to salable stock.

• Ensuring compliance with any additional product-specific legal requirements.

• Create, review, and approve Standard Operating Procedures (SOPs) and other quality documents as necessary.

MINIMUM QUALIFICATIONS:

• Master’s degree with 3-5 years of relevant experience or a Bachelor’s degree in a scientific or health-related field with 5+ years of relevant experience.
• Alternatively, a comparable background may be considered.

PREFERRED QUALIFICATIONS:

• Bachelor’s degree in a scientific or health-related field with extensive GDP and GMP experience.
• 5+ years of experience in a quality assurance role.
• In-depth knowledge of GDP to ensure operations uphold product quality and compliance.
• Strong communication and interpersonal skills with the ability to influence in areas where there is no direct reporting authority.
• Auditing skills are an advantage, with relevant qualifications in auditing preferred.
• Proficiency in English and fluency with Microsoft Office applications (Word, Excel, PowerPoint).

This role offers the opportunity to make a tangible impact on product quality and patient safety by ensuring adherence to strict quality standards and regulatory requirements. If you are detail-oriented, enjoy collaborating with cross-functional teams, and have a passion for maintaining excellence in product distribution, this role is an excellent opportunity to contribute to operational quality on a significant scale.