Global Quality Compliance Microbiology / Aseptic Network Leader
Global Quality Compliance Microbiology / Aseptic Network Leader Apply Now Job ID1602327 Date posted10/04/2016 LocationCambridge, Massachusetts, United States; Deerfield, Illinois, United States; Zurich, Switzerland;
More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. As a global, research and development-driven pharmaceutical company, Takeda Pharmaceutical Company Limited conducts R&D both internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology and central nervous system, plus vaccines. Novel products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!
- Build and sustain network knowledge and expertise in microbiology and aseptic operations to assure sustainable product supply via overall Compliance Network activities
- Deliver and drive continuous improvement by influence on microbiology strategies at the site level via collaboration and engagement with regional/business Quality and GMS, R&D and Vaccines leadership
- Actively engage external to Takeda to assure internal procedures and technology are up to date, competitive and compliant with current Good Manufacturing practices.
- Engage with the different regions and sites to proactively assure positive outcomes with external inspections
- Provide Subject Matter Expertise in preparation and review of appropriate responses submitted externally to global Boards of Health
- Partners actively and effectively with Global Auditing to provide support as needed, with emphasis on targeted Due Diligence and Business Development activities.
- Collaborate with site leadership to assure microbiological structure and capabilities to deliver sustainable supply of products via engagement with Global Quality leadership and ongoing initiatives, such as AGILE
- Establish and sustain key partnerships with Global Manufacturing Supply, Engineering, and Development and Vaccines to assure proactive implementation of effective microbial/aseptic strategies.
- Provide timely and effective review of microbial and aseptic practices, procedures, and on-going metrics
- Provide routine support to network via site visits, effective tele/video-communication as needed
- Provide subject matter expertise when required for Quality escalation processes, such as Quality Alignment, Market action, or Quality Council activities
- Review capital investment plans reviews as needed to assure sustainable microbial and aseptic capabilities
- Develop effective subject matter training materials and programs to assure appropriate expertise at site and regional levels to support ongoing product supply
- Participate in preparation and maintenance of global policies, standards, and procedures as required
- Build and develop key technical and leadership competencies within the network,
- Be a role model for Takeda-ism and provide positive representation of Takeda when dealing with internal and external partners
- Promote a positive Quality Culture and Leadership Behaviors as defined and launched by Global Quality and Takeda, respectively.
- Provide technical concurrence on significant microbial or aseptic investigations/incidents as needed
- Support inspection preparation activities at sites prior to significant inspections as required
- Lead efforts to define and establish Center of Excellence with appropriate succession planning
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor’s Degree in Microbiology, Pharmaceutical Science or equivalent. Masters degree a plus.
- Minimum of 15 years professional working experience in pharmaceutical manufacturing, Quality Control, Quality Assurance or related compliance experience with at least 10 years managing audit processes for GMP / GDP, ISO and ICH, and at least 5 years’ experience supporting FDA, EMA, PMDA and/or other regulatory health authority inspections.
- Strong knowledge of regulations pertaining to pharmaceutical manufacturing and distribution in US, Europe and Japan. Ability to develop knowledge of regulations in other markets as required.
- Working knowledge of a pharmaceutical manufacturing technologies used for a variety of pharmaceutical formulation types
- API production
- Sterile products – aseptic process and terminal sterilization
- Solid dose
- Liquid, suspensions, suppositories, pastes
- Biological processes for large molecule products
- Strong knowledge of Pharmaceutical Laboratories, technologies, systems and processes.
- Ability to influence and work effectively across various regions and cultures.
- Strong interpersonal skills including listening, judgment, conflict management, ability to lead teams in a global environment.
- Proven leadership in managing risks and resolving conflicts to achieve positive outcomes
- Ability to anticipate potential problems and risks related to quality system / regulatory expectations including ability to formulate and implement solutions.
- Demonstrated collaboration within and across functions, initiative and problem solving skills.
- Strong oral/written communication skills appropriate for diverse international collaboration including excellent fluency in English and regional languages as needed.
- 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
- International travel is a requirement
- Significant travel is expected
- Site support; External engagement - as needed
we are driven to improve people's lives
Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.