Sr. Manager, Global Distribution Quality - Incyte Corporation

Job Summary  (Primary function)

This position will provide support to the Global Distribution team in the area of Packaging & Distribution. The individual will be responsible for the Quality oversight of product distribution activities in the assigned territories (North and South America, East Asia) and ensure that commercial product is distributed to end-customers in compliance with the quality requirements and standards for small and large molecule commercial products in a GMP regulated environment. 

This role will provide prompt support and guidance to patient’s inquiries and facilitate cross-functional activities to resolve issues related to Quality systems, manufacturing/packaging, distribution, and post market surveillance related to Incyte products.  The person in this role will continuously inform and improve the systems process while effectively working with cross-functional teams. 

Essential Functions of the Job  (Key responsibilities)

• Manage the Incyte Distribution network in line with regional scope.
• Provide the QA expertise and input for the conduct of Distribution Risk assessments in the assigned regions.  Escalate the potential strategic risk through the GMP GDP Risk Management program and the MRB process.
• Support the execution of mock recalls and support global recall processes.
• Lead QA duties for the selection, approval, and qualification of new suppliers in assigned territory in line with scope of vendor responsibility.  
• Perform internal and/or external audits as Lead Auditor in accordance with Incyte audit program.
• Develop and maintain Quality Agreements in the assigned territories.
• Represent QA for New Product/Market launches and oversee related Change Controls.
• Ensure compliance of Incyte Products by reviewing, approving, and ensuring maintenance of Packaging & Shipment Specifications with new product introduction and product expansion.
• Develop, maintain and roll-out SOPs in line with scope of activities.
• Lead the resolution of Packaging & Distribution related CAPAs, deviations and logistic events.
• Record, assess and reconcile Product Quality Complaints while coordinate collection of additional information from external and internal stakeholders (i.e. patient, Pharmacies, etc)
• Lead the QA part in Quality Business Reviews performed with key 3PLs/Distributors and Partners.
• Complete review and approval of packaging component artworks and proofs review for existing and new product introductions for responsible markets.
• Cooperate with the US Supply Chain, CMC, QC and RA functions in matters relating to commercial Product.
• Manages and organizes the batch disposition activities across commercial products to ensure compliance and timely supply of products.
• Stay current with the applicable regulations and promote Quality across the Incyte organization.
• Support Annual Product Review issuance.
• Perform all responsibilities in accordance with company policies, procedures, applicable regulations, and safety requirements.
• Stay current with applicable International Regulations and promote Quality across Incyte organization.
• Contribute positively to a strong culture of business integrity and ethics.
• Continuously promote the Quality culture in all interactions both internally and externally.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Bachelor’s degree, preferably in a scientific discipline, with 8 years in pharmaceutical or biotech industry, preferably in Quality related roles.
• Experience with Quality oversight of Contract Manufacturers.
• Thorough knowledge of cGMP, GDP and global regulatory requirements.
• Ability to multitask and work both independently and within multi-disciplinary teams.
• Ability to critically appraise and apply GxP knowledge.
• Strong verbal and written communications skills.
• Strong interpersonal skills for effective professional communications, aiming to cultivate strong working relationships with both internal and external groups and to promote quality and GxP compliance.
• Travel up to 10%