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Estimated Pay $53 per hour
Hours Full-time, Part-time
Location Lebanon, Pennsylvania

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About this job

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s and . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job DescriptionAbout the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Director, GRA CMC Business Process Excellence where you will Work within the organization and with all levels of staff to advance the objectives and vision of the Head of Regulatory CMC & Device and establish a strategy and roadmap that translates goals into tactical plans As part of the GRA CMC Business Process Excellence team you will report to the Head of Global Regulatory Affairs CMC Business Process/Process Excellence and Systems.

How you will contribute:
  • Ensure project management support and facilitation of the Regulatory CMC & DEVICE Leadership Team; coordination and preparation for meetings and tracking of required actions until completion.
  • Lead and coordinate GRA CMC Transformation including but not limited to planning, development, automation and implementation of tools, processes and systems.
  • Support the Head of Regulatory CMC & DEVICE with regard to issue resolution, current and future initiatives, strategies, resource planning, and budgets.
  • Manages resourcing, builds and leads matrix teams and reports project status to stakeholders and Sr. Management on a regular basis.
  • Provide real-time input to support decision making by Regulatory CMC & Device Leadership Team.
  • Engage and lead strategic discussions focused on Financial Planning, Budgeting, Resource Planning and other business operations. Provides recommendations based on analysis with quantifiable opportunities to drive optimization.
  • Serve as a subject matter expert for CMC Business Operations, handling inquiries and developing action plans to address them, and assisting with preparation and disseminations of communications.
  • Monitor progress of Regulatory CMC KPIs, intervening as necessary to ensure that CMC & DEVICE Regulatory is on track to meet or exceed performance targets. 
  • Identify, lead and support process optimization projects and non-drug projects that the improves business process performance (productivity, efficiency, effectiveness).
  • Work with CMC Leadership to identify key opportunities for cross-functional optimization and secure organizational sponsorship to effectively implementation solutions.

Technical/Functional (Line) Expertise

  • Comprehensive understanding of the pharmaceutical industry and 12+ years experience in Regulatory Affairs and overall drug development process.
  • Project-management expertise, demonstrated ability to lead multiple, complex projects from inception to close-out
  • Process Improvement expertise and experience (Six sigma, LEAN, and/or PMP certification or equivalent desirable)

Leadership

  • Demonstrated ability to work across functions, regions and cultures
  • Ability to influence, inspire, motivate and drive results without direct authority
  • Outstanding communicator, able to persuasively convey both ideas and data, verbally and in writing
  • Proven skills as an effective team player who can engender credibility and confidence within and outside the company
  • Ability to distil complex issues and ideas down to simple comprehensible terms
  • Demonstrates leadership presence and confidence
  • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
  • Invests time in helping others to enhance their skills and perform at a higher level

Decision-making and Autonomy

  • Provide input to highly complex decisions that impacts across functional areas
  • Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
  • Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution 
  • Accountable for providing inception of and implementing vision and strategy for designated scope

Interaction

  • Expertly navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
  • Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
  • Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner
  • Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions

Innovation

  • Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation
  • Comfortable challenging the status quo and bringing forward innovative solutions
  • Ability to take risks implementing innovative solutions (process automation where appropriate), accelerating time to market
  • Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business
  • Role models respect and inclusion, creating a culture that fosters innovation

Complexity

  • Ability to work in a global ecosystem (internal and external) with a high degree of complexity
  • Ability to see and understand broader, enterprise level perspective of CMC within the pharma drug development lifecycle
Qualifications:
  • Bachelor’s degree or related experience is required. Scientific or closely -related field preferred; Advanced degree preferred
  • 12+ years of  experience in the pharmaceutical/biotechnology industry with direct leadership experience in Regulatory Affairs, CMC and/or in an allied area.
  • Management experience in R&D operations or related field, leading and influencing senior-level management and key stakeholders
  • Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
  • Six sigma, LEAN, and/or PMP certification or equivalent desirable
  • Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
  • Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.
What Takeda can do for you
  • Comprehensive Healthcare: Medical, Dental, and Vision
  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs and company match of charitable contributions
  • Family Planning Support
  • Flexible Work Paths
  • Tuition reimbursement
More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

The position is currently classified as hybrid in accordance with Takeda’s Hybrid and Remote Work policy

Base Salary Range: $160,300 to $229,000 based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time