Quality Assurance, GDP (Good Distribution Practice) Operational

Title: Sr Specialist, GDP Operational QA

Location: Boston, hybrid 3x/week onsite

Duration: 12m

Must Have:

• GDP (Good Distribution Practices)
• Third-Party Logistics/Supply Chain (Finished Goods)
• QA background (QMS, CAPA, Change controls)

The ideal candidate will have experience/knowledge in a GDP (Industry) environment, Distribution, Supply Chain and Logistics.

Key Accountabilities:

• Support the oversight of Distribution Partners within the USA, including:
• Preparation and maintenance of Quality Agreements
• Review of deviations, CAPA and changes
• Maintaining KPIs
• Analyze, resolve, or assist in solving compliance and customer issues.
• Escalation of issues
• Finish Goods Release at 3PL
• Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMS
• Accountable for New Product Launch activities within the US providing distribution requirements and expectations.
• Working collaboratively with key internal stakeholders
• Support Clinical QA Distribution

Key Responsibilities:

• Maintain QMS within the client.
• Ensure distribution licenses (where required) accurately reflect the current organization, vary license where necessary
• Support recalls, mock recalls and any other on-market activity.
• Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.
• Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches.
• Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Distribution licenses (or equivalent) application, audits, and Quality Agreements.
• Planning/ Preparation/supporting/hosting for Regulatory inspections
• Providing front and backroom inspection support
• Post inspection follow-up with responses and CAPAs (Continuous improvements)
• Manage/Approve/Assess event investigations “deviations” (including Fast Track deviations)
• Manage CAPAs and Effectiveness Checks
• Perform other duties as per GDP guidelines and policies and procedures
• Work with Product Complaints team to ensure that customer complaints are dealt with effectively.
• Ensure that customers and suppliers are approved
• Approving any subcontracting activities that may impact GDP.
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
• Deciding on the final disposition of returned, rejected, recalled or counterfeit medicines, including the approval of returns to saleable stock.
• Ensure that any additional requirements imposed on certain products by national law are adhered to.
• Create/review and approve Standard operating Procedures and other Quality Documents

Preferred Qualifications:

• Bachelor's in a scientific or allied health field and relevant GDP & GMP work experience, or relevant comparable background.
• 5 years’ experience serving in a Quality role.
• Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.
• Influencing skills in areas with no direct reporting authority.
• Strong interpersonal and communication skills.
• Auditing skills, appropriate qualifications in auditing an advantage.
• Fluency in English is required
• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)