SUMMARY OF POSITION
The Senior Director TPQ (Third Party Quality) develops strategic direction and provides the governance/oversight of the TPQ Operations. The Sr. Director TPQ leads the team that directly interacts with Alvogen’s external business partners/CMOs and has responsibility for these products throughout the entire lifecycle (i.e. from development through discontinuation). This individual is a critical link between Alvogen’s external partners and the internal Alvogen team (e.g. Operations, Supply Chain, Business Development, R&D, Product Launch, Regulatory Affairs, Global / Corporate Quality, etc.). The individual will also be responsible for TPQ’s Quality Management System (cGxP Compliance) and for supporting Alvogen’s Global / Corporate Quality Group with Quality Management Systems improvements / enhancements.
The Senior Director TPQ reports in to the Executive Vice President Global Quality. The Director Third Party Quality Non-Sterile Products, Director Third Party Quality Sterile Products, Sr. Manager US Quality Systems, and all associated staff report up to the Senior Director TPQ.
Primary responsibilities of this role include the following:
- Leadership – As a senior leader in the Quality organization, the incumbent will have primary responsibility for setting the strategic vision for the TPQ team as well as ensuring execution of the vision while supporting the business needs
- Operates as a surrogate for the Global Head of Quality on an as needed basis
- TPQ Departmental Support
- Provides leadership, support, guidance and direction to TPQ team on activities such as: validation, troubleshooting/ investigation support, complaint handling, change control, product release, inspection support, technical transfers to/from various CMO’s, etc.
- Serves as an expert in dealing with Regulatory agencies
- Works with the Global and Local Quality teams to continuously improve Quality Systems and personnel
- Develops and adheres to an organizational budget
- Ensures an environment of continuous improvement
- Keeps abreast of regulatory compliance initiatives/guidance and industry standards
- Implements, maintains and ensures adherence to the Alvogen QMS
- Assures all third-party partners are in compliance with all appropriate regulations
- Assures that all third-party partner products meet requirements
- Oversees Customer Complaints
- Oversees Training
- Oversees TPQ Pine Brook’s Internal Audit Program
- Oversees TPQ’s Metrics Reporting & TPQ’s ‘Quality Council’ Activities
- Oversees TPQ’s Risk Mapping / CMO Evaluation Reporting
- Interdepartmental Support
- Partners with Supply Chain and represent US TPQ in the Sales Inventory and Operations Planning process
- Partners with R&D, the Product Launch Team, etc. to support the launch of US products from CMO’s and internal Alvogen sites
- Due Diligence – Is the primary Quality point of contact with Business Development during the acquisition of new products and/or facilities. Must have Solid knowledge of cGXP and experience performing audits
- BS in Technical Field – Chemistry, Biology, Microbiology, Pharmacy or related field; MS in technical field preferred
- More than 15 years’ experience in different quality related roles within the pharmaceutical industry and experience with multiple dosage forms, including sterile products, medical devices and biologics preferred.
- More than 10 years’ experience as a manager across multiple departments/ functions of the Quality organization (e.g. QA, QC, etc.).
- Excellent oral and written communication skills. Must be able to effectively communicate to resolve conflicts and generate buy-in when dealing with complex situations. The individual must be a credible and confident communicator with good presentation skills (written and verbal)
- Strategic thinker with the ability to influence at senior levels
- Excellent critical reasoning, decision-making, and system thinking skills
- Thorough understanding of US FDA, EU and other regulatory agency expectations. Solid knowledge of cGXP and experience dealing directly with regulatory agencies
- Proven ability to set vision of excellence and holding organizations accountable for compliance and quality standards
- Experience in leading cross functional teams and managing in a fast-paced lean organizationPhysical Demand Factors
- While performing the duties of this job, the Senior Director TPQ is required to sit and work at a computer for extended periods of time.
- Is regularly required to talk, listen, and attend meetings / teleconference calls.
- Approximately 25-30% business travel required to external Contract Manufacturing Organization (CMO) / Business Partner sites, to attend professional development training seminars, or otherwise as directed by the Executive Vice President Global Quality.
GMP DECISION-MAKING AUTHORITY
Independent decision-making activities will be performed by the Senior Director TPQ for all the elements outlined in the Responsibilities section of this Job Description.
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