Vaccines Global Quality Product Leader - Vaccine Business Unit - Switzerland
- Designs appropriate Quality Strategies and processes to ensure that the Global Vaccine Products have effective and efficient quality oversight and control of manufacturing operations which are critical to the quality, compliance, and supply of Takeda product to Global partners.
- Provides leadership when significant compliance and safety risks arise from the manufacture, packaging, testing, labeling, transportation and distribution of Takeda product to ensure immediate protection of subject or patient safety and compliance with current regulations and company standards.
- Analyzes potential Quality and compliance risks in global supply channels which impact Takeda product or services and develops appropriate risk mitigation strategies to minimize risks.
- Reviews existing and new strategic partnerships, provides leadership in the design of the Quality accountabilities across Takeda internally and/or our strategic partners, and gains agreement with key quality partners to ensure that Takeda’s and partners compliance requirements are met, and ensuring risk based utilization of Takeda resources.
- Represents Takeda and senior management at key meetings with Takeda Corporate and Regional QA management, Regulatory Agencies and business partners.
- Maintains culture of teamwork, cooperation and continuous improvement.
- Maintains expertise in international GMP (FDA, EMA and JP) and compliance requirements through interaction and networking with Quality leaders across the industry through professional organizations, leadership conferences and training.
- Ensures site Global Vaccine Products compliance through regulatory inspections readiness & success, tracking of metrics and KPI’s towards problem recognition and prevention, managing product complaints trending and investigations, and comprehensive risk management practices. Report Global Product compliance with local and global Quality Councils.
- As the Global Vaccine Product Leader, the colleague will make quality and compliance decisions regarding global vaccine products. Represent Takeda and senior management at key meetings with Takeda Corporate and Regional QA management, Regulatory Agencies and business partners.
- Assures consistency in achieving product quality and compliance by partnering with internal Takeda manufacturing sites and/or across multiple Contract Manufacturing Organizations (CMO)s.
- In consultation with the manufacturing sites, support or act as primary quality operations liaison with the Boards of Health to ensure consistency in global product quality and compliance communications and responses.
- Manages execution of global product quality strategy and drive changes to support manufacturing product transfers across the internal and CMO network.
- Manage quality approval of global drug substance, drug product, and component specification changes.
- Influences regulatory strategy development for global products, for example: supplements/variances, renewals, and CMC Maintenance – Annual Reports and assure consistency of regulatory filings for assigned product(s).
- Supports product inspections from global Regulatory Authorities, support conformance with regulatory filings, and support product recall activities by providing guidance and knowledge of regulatory requirements
- Takeda Global Quality leaders
- GMS Leadership
- TPUSA and Global Technical Operations
- Corporate alliance partners and Takeda distribution partners
- Contract Manufacturing Organizations and Contract Testing Facilities
- Supply management
- Product Development, CMC Team Leaders
- The Medical Division (Medical, Clinical Operations, Regulatory, and Pharmacovigilance)
- Proven leadership skills and being able to involve several levels of an organization to successfully meet the objectives
- Experience working with complex, global organizational and ability to work across functions and with all levels of the organization where the incumbent may not have direct authority
- Demonstrated excellence in developing & managing effective teams
- Undergraduate degree in a technical discipline required
- Minimum of 15 years experience in the Pharmaceutical industry with significant experience in biologics, vaccines, and/or biopharmaceuticals
- Minimum of 10 years experience in QA/QC with increasing responsibility
- Minimum of 8 years of management experience
- Demonstrated knowledge of GMPs, compliance issues, inspectional trends, industry quality assurance practices and systems, and personal management skills