Associate Director, Supplier Quality Management - Philadelphia, United States - Lilly

Lilly

Verified Company

Philadelphia, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana.

Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

The Associate Director, Supplier Quality Management, Avid leads quality oversight of a global supplier program supporting the manufacture of PET drug radiopharmaceuticals.

The individual is responsible for fulfilling the quality oversight and management of suppliers and service providers involved with the manufacture of components, materials, custom materials, starting materials, warehousing, and logístical services.

The position works closely and collaborates with Supply Chain, Global Investigational Product and Commercial Quality Assurance, CMC functional teams and Contract Manufacturers to ensure qualification and management of suppliers and service providers providing both custom and off the shelf materials utilized in the manufacture of PET drug product.

This role establishes and maintains standard operating procedures in alignment with corporate quality standards and current GMP expectations.

In collaboration with QA management, this position provides strategies, and solutions to achieve these responsibilities, improve the local quality system, and identify workstream efficiencies.

Key Objectives/Deliverables**:

Leads the identification, qualification and quality oversight of GMP suppliers and service providers
Designs and contributes to the design of the riskbased supplier quality management program and leads efforts for periodic review and updates of established procedures in alignment with Lilly quality standards
Manages established supplier reporting systems and prepares supplier performance metrics and risk determination in alignment with Lilly global standards
Connects and communicates with suppliers to acquire supply chain and quality information
Collaborates with associated Avid/Lilly team members and external contract manufacturing partners to ensure supplier problem resolution
Develops content and ensures execution and maintenance of supplier quality agreements
Coordinates the scheduling of supplier audits with corporate quality team members and serves as an audit team member, as required
Leads management and evaluation program for supplier change notifications and complaint/corrective actions
Accountable for the Manufacturing Materials Review Board for supplier performance
Supports and contributes to drug product annual product reviews
Manages review and release of packaged intermediate and reference standard materials
Educates and mentors team members on quality requirements and supplier management

Basic Requirements:

Bachelor's degree or advanced degree (i.e., Masters, PhD ), in a scientific discipline relevant to drug discovery, development, pharmacy, biology, or chemistry and a minimum 10+ years' experience in pharmaceutical or medical device manufacturing Quality Assurance with at least 3 of the years' relevant to parenteral product production and/or device manufacturing

Additional Skills/Preferences:

Strong knowledge of commercial and investigational drug product supplier quality management
Experience writing and revising Quality Agreements
Experience in leading risk evaluations and risk management
Proficient in root causes analysis, review and approval of deviations/investigations, quality assessment of CAPA Plans and change controls
Ability to simplify complex processes/problems and propose alternate solutions
Quality oversight experience with third party/contract manufacturing
Demonstrated negotiation and influence skills
Demonstrated written, and interpersonal communication, and project management skills
Knowledge of PET radiopharmaceutical manufacturing GMP's
Able to communicate effectively in both written and verbal forms to both internal and external customers

Additional Information:

Ability to travel domestically and internationally from 1025%, as required
Preferred location Indianapolis or Philadelphia and remote will be considered

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles

Our current groups include:
Africa, Middle East, Central Asia Network, African American