Head Of R&D Quality & Compliance

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Job Description
Job Title: Head of R&D Quality & Compliance
Location: Lexington, MA
About the role:
As the Head ofQuality & Compliance on the R&D Quality, Compliance & Systems (QCS) Team, you will manage the Quality and Compliance Team within the R&D organization, partnering with R&D Functional Compliance leads on compliance topics and lead strategic actions to reduce and resolve issues across Good Research Practice (GRP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) areas. You will report to the Head of R&D Quality, Compliance and Systems.
How you will contribute:

• Ensure adherence to Takeda QMS and regulatory requirements to guarantee an overall state of compliance. Quality and compliance subject matter expert, driving risk-based and actions across the enterprise.
• Be a strategic compliance partner and lead within the R&D Quality organization for moderate to complex compliance issues, representing the R&D Quality, Compliance and Systems (QCS) team through active leadership in compliance related projects.
• Lead compliance improvement through chair/co-chairing quality processes, including Quality Management Committee (QMC) meetings and post Health Authority (HA) Inspection alignment meetings, that directly support enterprise compliance initiatives to address complex and systemic issues.
• Partner with quality and compliance leaders to develop and implement corrective and preventive actions based on trends and identification of systemic issues (examples: ensuring audit trail reviews and data integrity requirements are in place across the enterprise, ensuring risk based and broad compliance mitigations and corrections are in place, identifying and aligning risks across GxP areas).
• Provide expertise and guidance in interpreting health authority regulations, guidelines along with internal Takeda policies, partnering with R&D Quality functions and Compliance leads to ensure assessments and implementation of GxP document updates.
• Execute and lead Acquisition/Divestment GxP activities for R&D QCS-owned documents and systems. Coordinate QCS-led acquisition/divestment activities across R&D Quality functions.
• Quality approver for global document gap assessments, including assessing R&D QCS GxP documents for impact. Direct functional areas with assessment of GxP documents to new and revised regulations and Takeda QMS updates.
• Accountable to identify, maintain, and manage overall compliance activities across departments and at the enterprise level to drive a state of compliance. Drive CAPA and effectiveness check requirements and improvements, in partnership with applicable Quality functions, to ensure complex and systemic issues are addressed promptly.
• Represent R&D QCS as a compliance subject matter expert during audits and Health Authority inspections. Is a leader in ensuring Takeda's responses to HA inspections and that they include broader, strategic actions that may be needed to guarantee an overall state of compliance.
• With QCS leadership team ensure processes and forums (Community of Practices, Compliance forums) are in place to drive upskilling and expertise across the organization.
• Is an expert current on industry trends and new/revised regulations and guidance's, using a framework and standard approach for ensuring the organization assesses and updates GxP processes and systems.

What you bring to Takeda:

• Bachelor's degree required, Master's degree would be ideal.
• Minimum 10 years Quality, GCP or GVP-related experience in a pharmaceutical or related environment.
• Experience in complex organizational and compliance issues and working to implement actions and improves processes across Quality teams.
• Prior experience with quality or clinical development teams to improve overall organization performance for key processes.
• Expertise within Clinical or Pharmacovigilance areas.
• Expert knowledge of relevant regulations (GCP, GVP, GMP, GPSP) and Quality and Regulatory concepts

What Takeda can offer 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 Ways of Working
• 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.
This posting excludes Colorado applicants.
#GMSGQ #ZR-1 #LI-MA1
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.
Locations
Lexington, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time