Product Quality Lead - Partnerships and Commercial
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.
What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.
Life at Takeda
A Global Top Employer
Recognized for our culture and way of working, we’re one of only select companies to receive Top Global Employer® status for 2020.
At Takeda, your determination and energy, combined with our cutting-edge technology and global R&D, offers families and communities hope for Better Health and a Brighter Future.
Learn more about Manufacturing, Supply Chain, and Quality careers within our global biopharmaceutical company.
At Takeda, there is an unwavering commitment to putting patients first, and to creating a workplace that is underpinned by empowerment and focused on diversity, collaboration and steadfast values.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Here, you will feel welcomed, respected, and valued as a vital contributor our global team.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Product Quality Lead - Partnerships and CommercialApply Now
The Product Quality Lead – Partnerships and Commercial, will provide global quality oversight of Takeda’ products, across the assigned product technology platform, from late clinical development phase through commercialization and throughout lifecycle. They will participate in development of strategy to proactively minimize product quality risks during product development, technology transfer, and commercial operations and work on deployment of the strategy for global processes as well as for assigned projects. The PQL is the quality liaison between Regulatory Affairs and Operations to ensure compliance of GMP operations in support of assigned programs. The role enables efficient communication and decision making related to the quality aspects across the Global Product Teams, manufacturing sites and global functions. They are the designated accountable representative for decision making in assigned projects, in consultation with business partners and management.
- Implementation of defined strategy for In-Licensing and Out-Licensing
- Manages assigned partnerships where product is out-licensed i.e. where ownership belongs to third party or shared with Takeda
- Responsible for Quality Management of Joint Venture in Russian Federation.
- Quality lead and Business Process Owner for Product localization
- Connects regional / local quality to the Global Product Teams in order to support geographical expansion and product launch
- BSc. / BEng. or equivalent essential, MSc./Eng. preferred, business related post graduate education an advantage.
- Minimum 8 – 10 years experience across a range of quality and technical operations, experience operating at global level essential
- Leadership experience of managing globally located teams is a must.
- Subject Matter Expertise in Biologics product platform is highly preferred.
- Sound knowledge of worldwide cGMP requirements is a strong asset.
- Expert on Russian GMP requirements and other Russian pharma related requirements is a must.
- Experience with working with Contract Manufacturing Organizations and Joint Ventures is a must.
- Experience with auditing and leading Quality Improvement Plans at CMOs / JVs is a strong asset.
- Good knowledge of product localization projects and technology transfers is highly preferred.
- Ability to work autonomously, and an understanding of when to consult/inform/escalate
- Strong relationship building skills, and ability to work in partnership cross functionally with global stakeholders
- Fluent in English and Russian is a must.
- Willing and able to travel up to 50 % of time, including territory of Russian Federation is a must.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Job ID SR0046418