Senior Manager, Supply Chain Quality Lead
About The Position
The Sr Manager, Supply Chain Quality Lead is responsible for providing oversight and support to all distribution quality related activities within the USA. They are responsible for developing quality awareness and inclusion in all processes and facilitate or mentor processes required for the establishment of effective quality management systems. The Sr Manager will liaise with all functions within our Pharma Operations & Technology division and outside to assure seamless processes and patient access to medicines. This person will have QA oversight of logistics of products' distribution worldwide and management of deviations, CAPAs, Change Controls, audits and serialization.
Requirements
- Bachelor's Degree required, preferred in life sciences, supply chain, or other related
- Minimum of 7 years of GMP and/or GDP (Good Distribution Practices) experience for medicinal/pharmaceutical products within a Quality Assurance logistics environment
- Quality and distribution expertise, including cold chain and deep frozen products
- Outstanding communication skills inclusive of delegation, influencing, stakeholder management, and networking abilities
- Ability to work independently to drive projects to completion
- Vendor Management experience
- Demonstrated experience in resolving distribution issues impacting medicinal products
Nice To Haves
- Experience supporting global teams across multiple time zones
Responsibilities
- Ensure quality and uninterrupted supply through the application of quality measures throughout the supply chain to the patient, as well as the appropriateness of quality systems to stay in compliance with regulations
- Approve shipping qualification for passive and active cooling in transportation, provide support for ex-US internal logistics shipping qualification
- Ensure regulatory inspection readiness for distribution
- Provide oversight of distribution related procedures for USA including oversight of distribution partners
- Establish and maintain Quality Agreements to assure product quality and uninterrupted supply
- Hold regular Quality Management Reviews with distribution partners and monitor performance against applicable KPIs
- Manage specific projects related to product distribution and improvement of standards and compliance
- Support the governance process of Global Commercial Quality
- QA Management of processes related to suspect or illegitimate medicines, returns and recall
- Quality support of pipeline growth and continuous supply of product
- Participate in the new product launch team for planning and identify associated quality actions need to be implemented in preparation for product launch
- Other duties as assigned
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Industry
Chemical Manufacturing
Number of Employees
5,001-10,000 employees
