Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Head of R&D Clinical Quality Assurance in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
- Leads the global Research and Development Clinical Quality Assurance function, providing sponsor quality oversight of clinical development activities for global and regional development programs.
- Ensures that investigator, supplier, scientific report, trial database, and Trial Master File audits are conducted, communicating any critical compliance risks identified from these activities to senior management, and ensuring that corrective actions are implemented.
- Serves as a senior strategic GCP resource to Takeda for its drug development activities, and takes a lead subject matter expert role for the preparation, conduct, response, and follow-up to health authority inspections of Takeda s development activities.
- Collaborates with R&D Quality, Global Quality, R&D operational functions, and suppliers of outsourced services to ensure that clinical trial activities sponsored by Takeda are conducted in compliance with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and Takeda requirements.
- Leads the Clinical Quality Assurance function in the development, implementation, and refinement of processes to ensure that Takeda maintains sponsor oversight of the quality of its development activities in compliance with applicable regulatory requirements.
- Serves in a consultative role for compliance-related matters and supports R&D in implementing corrective and preventive actions (CAPAs). Develops strategic, pragmatic initiatives to promote compliance.
- Sets the strategy and leads the development and execution of the audit program for R&D clinical trials, working collaboratively with stakeholders to ensure that the audit program is robust. Ensures that appropriate CAPAs are implemented in a timely manner. Identifies potential systemic gaps and coordinates with the appropriate stakeholders to ensure a timely resolution.
- Escalates issues of potentially critical non-compliance and/or lack of urgency in remediation to senior management. Analyzes results to identify actionable trends and to promote a state of compliance. Audit types include clinical investigator sites, clinical suppliers, protocols and scientific reports, Trial Master Files (TMFs), and study databases. results, quality issues and investigations in order to identify actionable trends and to promote a state of compliance
- Supports R&D to be inspection ready with a culture of sustainable compliance. Represents Takeda as a clinical quality subject matter expert during health authority inspections of the sponsor. Provides strategic direction to assure that responses are timely and appropriate to maintain Takeda s good standing with regulatory agencies. Ensure that all clinical inspection commitments are fulfilled on time.
- Identify and mitigate GCP quality and compliance issues with potential significant impact, and ensure that lessons learned are applied across global development programs.
- Determine acceptability of clinical suppliers for potential use by Takeda, and provide ongoing direction, guidance and strategy for supplier oversight.
- This position has overall responsibility for the ongoing development and operational success of the Clinical Quality Assurance, including talent development and succession planning, resourcing and budgeting, and alignment of Clinical Quality Assurance initiatives with R&D Quality and Global Quality.
- Lead talent management for Clinical Quality Assurance employees across the globe, in partnership with the R&D Quality Leadership Team and Human Resources Business Partners. Engage in projects to ensure people development across the network
- Serve as a member of the R&D Quality Leadership team, giving input to key strategic, portfolio, human resource and financial decisions.
- Serve as a strategic thought partner to the Head of R&D Quality with regard to complex problems affecting development activities, with an eye to current and future initiatives, strategies, and budgets.
- Ensure strong alignment with R&D Research Quality for the oversight of bioanalytical facilities that produce data for clinical trial data, and R&D Quality Compliance in the preparation for and management of health authority inspections.
- Conducts due diligence assessments.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Expert knowledge of GCP requirements, and good working knowledge of Good Pharmacovigilance Practice (GPvP) requirements for clinical trials.
- Advanced experience in auditing clinical investigator sites, clinical suppliers, TMFs, scientific reports, and clinical trial databases.
- Experienced in hosting/leading clinical health authority inspections.
- Good working knowledge of requirements for bioanalytical facilities that support clinical trials.
- Proficient in analyzing data to identify performance trends.
- Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues. Proven ability to proactively identify and lead the development and re-engineering of key processes and systems in support of the business s mission.
- Highly effective communicator who is capable of establishing a compelling vision for Clinical Quality Assurance.
Sets strategy for Clinical Quality Assurance in alignment with the priorities of the Takeda Therapeutic Area Units (TAUs), and in alignment with the Head, R&D Quality
- Outstanding leadership and interpersonal skills with a management style which encourages open expressions of ideas, opinions, and a full discussion of differing points of view.
- Clear, concise, and consistent in written and verbal communications.
- Ensures that every employee knows what is expected of their role and what it takes to be successful, and how they are progressing. Holds employees accountable to achieve results while demonstrating Takeda s values and strategic priorities of Patient, Trust, Reputation, and Business.
- Helps employees grow through challenging opportunities so that they may realize their full potential.
- Serves as a role model for being brave and taking appropriate risks, always in compliance with clinical trial regulations and Takeda requirements.
Decision-making and Autonomy
- Manages within the department budget established for Clinical Quality Assurance, and empowered to make hiring decisions within allotted headcount.
- Makes organizational design decisions in alignment with the Head of R&D Quality.
- Experience working within complex organizations, working closely with senior staff and executive level colleagues. The ideal candidate will have the acumen to handle complex situations and multiple responsibilities simultaneously mixing long term projects with the urgency of immediate demands on the operations. S/he must also have the demonstrated ability to deal with highly confidential information and act as a liaison between Head of R&D Quality and other executives.
- Demonstrated ability to collaborate with and achieve results through others, the ability to build strong and sustainable relationships and the capability to interact within all levels of the organization.
- Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal/regulatory documents.
- Effectively presents information to senior management, internal groups, external stakeholders and customers.
Leads clinical quality oversight for the entire R&D pipeline around the globe, requiring effective cross-cultural working skills and expert knowledge of GCP requirements across health authorities
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS/BA degree and advanced degree preferred.
- Advanced knowledge of clinical development processes.
- Minimum of 15 years of industry experience in Quality Assurance and/or Clinical Operations with majority in drug development, biotechnology, device, or related areas.
- GCP professional certification/registration preferred.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- 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
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.