Sr. Manager, Global Distribution Quality
Company: Incyte Corporation
Location: Wilmington
Posted on: October 16, 2024
Job Description:
Overview
Incyte is a biopharmaceutical company focused on the discovery,
development, and commercialization of novel medicines to meet
serious unmet medical needs in oncology and inflammation and
autoimmunity. Incyte is committed to the rigorous pursuit of
research and development excellence to improve the lives of
patients, make a difference in health care, and build sustainable
value. The Company strives to discover and develop first-in-class
and best-in-class medicines-advancing a diverse portfolio of large
and small molecules. Sr. Manager, Global Distribution Quality 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%
Keywords: Incyte Corporation, Brick , Sr. Manager, Global Distribution Quality, Executive , Wilmington, New Jersey
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