Title: Associate Director, Quality Operations
Location: Cambridge, MA
Duration: 6 months
Job Description:
- The Quality Operations Associate Director role is responsible for supporting commercial distribution activities, maintaining current Good Distribution Practices related to commercial product distribution.
- Management of outsourced third-party logistics service provider operations involved in managing commercial drug distribution.
- Release of commercial products for distribution.
- Management of and response to temperature excursions, product replacement requests, serialization issues, and logistics complaints for commercial products.
- Deviations, CAPAs and change controls related to GDP operations.
- Annual GDP training development.
- Ownership of local Vendor Management and external audit program.
- Maintaining KPIs and metrics related to GDP.
- Tasks as assigned related to GDP Quality Operations, including documentation management assistance, SOP writing and revision, audits and inspection support, and new product launches.
- Adherence to all applicable *** SOP’s, policies, and regulatory requirements.
- This role, reporting to the Sr. Director Quality Operations, will work in collaboration with GDP and GxP functions at the USA affiliate office, including Trade/Supply Chain and Regulatory.
- The Associate Director, Quality Operations is responsible for the release of commercial products onto the US market and potential outbound shipments for global markets.
- This role is responsible for establishing and maintaining relationships with manufacturing and distribution channels.
- This role is also responsible for ensuring compliance with policies and procedures relevant to appropriate distribution of commercial drug, as well as working with corporate to ensure external vendors involved in GDP storage and distribution are audited.
- Day-to-day management of third-party logistics service provider operations involved in commercial drug distribution.
- Distribution release of commercial batches to trade and for shipment to other markets, including review of shipping records and temperature traces for all international and domestic shipments of commercial product, certificates of analysis for accuracy and compliance, shipment and receipt documentation, and disposition of commercial drug product.
- Establishing and maintaining relationships with manufacturing and distribution channels.
- Review, assessment and responses to temperature excursions, product replacement requests, serialization issues, and logistics complaints for commercial products.
- Development and maintenance of Quality Technical Agreements.
- Quality oversight of temperature-controlled shipper qualifications.
- Communication, initiation, and management of any GDP related Deviations, CAPAs and change controls.
- Review and update Annual GDP training materials.
- Other tasks as assigned related to GDP Quality Operations, including documentation management assistance, SOP writing and revision, audits and inspection support, and new product launches.
- Completing and maintaining up-to-date training and training records on functions performed
- Adheres to all applicable *** SOP’s, policies, and regulatory requirements
Knowledge, abilities & experience Education / Certifications:
- Bachelor’s degree or higher, preferably in science related area.
- Minimum 12+ years of experience in Quality responsible for oversight of Good Distribution Practices and third-party logistics in a pharmaceutical or similar setting.
- SAP experience is preferred.
- Experience with electronic platforms for quality systems management and training.
Key Technical Competencies Required:
Knowledge of US GDP regulations and DSCSA requirements, cold chain shipping and shipper qualifications, and vendor qualification - Highly organized - Strong demonstrated communication skills - Agile in decision making, - Ability to collaborate across departments and levels. - Proficiency in Microsoft Office suite, including Word, Excel, and PowerPoint required. - Up to 10% travel required for this role.
