This position is responsible for developing, maintaining and continuously improving the quality assurance and compliance needs in the Good Manufacturing Practices (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), for the Vaccine Business Division (VBD). The position will ensure quality practices match global regulatory agencies and comply with Takeda’s quality assurance and compliance processes. This position is responsible for products in development and commercialized. The position is responsible for setting and communicating the QA vision, strategy, and organizational structure to meet VBD’s strategic goals.
Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Defines and articulates the vision and strategy for VBD Quality Assurance and Compliance which is in support of VBD’s vision and strategy and is aligned with TPC Corporate Quality Assurance policies and standards.
- Defines and articulates the strategy for the overall philosophy, scope and key elements of VBDs Quality Systems, including but not limited to training, SOPs, auditing, project support, vendor/CRO quality management, compliance oversight and regulatory intelligence.
- Ensures adequate human and financial resources are allocated to the function in order to fulfill the function’s commitment to the organization.
- Ensures an integrated approach to Quality Systems implementation across VBD. Ensures all relevant elements of VBD Quality Systems evolve to support any and all development and commercial functional changes as well as changes in the global regulatory environment.
- Safeguards development pipeline by ensuring that VBD development projects progress through development in a compliant fashion such that compliance issues will not result in failure to approve.
- Provides strategic input into TPC Quality System Design and other Quality initiatives
- Creates and maintains and ensures the global process for regulatory inspections and inspection readiness preparation is in place, up to date and followed.
- Directs the strategy and implementation of GCP, GMP, and GPL crisis management on a global basis
- Oversees global Regulatory Agency interactions related to compliance issues.
- Creates, maintains and oversees the leaders and systems responsible for regulated training strategy that is defensible from a global regulatory perspective and is designed to meet the highly technical training needs of the R&D and commercial technical environments.
- Oversees the leaders responsible for ensuring effective transition of development quality assurance from the laboratory bench to commercial compliance.
- Create and maintain a quality culture of transparency and efficient communication of quality related matters to achieve and maintain the desired high state of VBD quality across all VBD development and commercial operations.
- Ensure VBD QA budget alignment with Takeda businesses and divisions and manage to plan.
- Oversees the leaders responsible for product release (commercial and clinical trial material)
- Oversees the leaders responsible for Quality Oversight of all manufacturing facilities.
- Partners with CMC and Mfg in the selection, design and establishment of GMPs in vaccine facilities.
- Oversees the review of due diligence opportuniti4es as requested.
- Bachelor’s degree in Science; Masters or PhD in Life Sciences preferred. 12 – 15 years applicable experience within the pharmaceutical industry, including a minimum of 5 years of vaccine QA leadership experience.
- Advanced knowledge of global and local regulatory GXP requirements.
- Familiarity with regulations and regulators worldwide.
- Significant demonstrated leadership and experience in complex global Quality organizations, including experience leading multi-cultural teams and interacting with executive management.
- Strong interpersonal and communication skills, must understand how to influence and diplomatically challenge when needed.
- Demonstrated ability to initiate and drive change across an organization.
- Demonstrated courage in difficult situations.
- Demonstrated ability to lead matrix organizations across multiple geographies and functions.
- Demonstrated ability to deal with and manage urgent and crisis situations with sound and quick decision making.
- An advanced understanding and demonstrated experience in the regulated aspects of pharmaceutical drug development and commercial operations.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while traveling.
TRAVEL REQUIREMENTS :
- Willingness to travel to various meetings or client sites, including overnight trips. International travel required.
- Requires approximately 35-40% travel.
We are driven to improve people's lives.
We are an equal opportunity employer.
No Phone Calls or Recruiters Please.
Takeda Pharmaceuticals - 6 months ago