Sr. Manager, R&D Quality Compliance and Systems

Takeda • Lexington, MA

19h

About The Position

As a Sr. Manager, R&D Quality Compliance and Systems, you will provide cross functional expertise and input to the quality systems supporting Takeda’s R&D Quality organization across the RDQ enterprise and ensuring that it is robust, aligned with, and compliant to applicable regulatory requirements, and governed and positioned for continual improvement. You will provide key input to the establishment of the framework for quality oversight of the R&D Quality Management System. Serve as a Quality Partner across R&D Quality and contribute to the design, implementation and advancement of the R&D Quality Management System operations.

Requirements

• Working knowledge of current GxP (e.g. Good Manufacturing Practice, Good Laboratory Practices, Good Clinical Practices, Pharmacovigilance) requirements for the pharmaceutical industry.
• Experience in compliance and systems related processes and tasks.
• Experience with risk management strategies and general project management.
• Proven success in identifying and implementing continuous improvement initiatives.
• Proficient in analyzing data to identify performance trends.
• Ability to proactively manage the development and re-engineering of key processes and systems in support of the business’s mission.
• Able to manage projects, programs and tasks with little, to no, oversight.
• Able to analyze data and make recommendations to management and/or escalate as appropriate.
• Experience working within complex/matrixed organizations.
• Ability to read, analyze and interpret common scientific and technical data/reports and legal/regulatory documents.
• Effectively presents information to management, internal groups, and stakeholders.
• Ability to anticipate potential problems and risks related to quality expectations and regulatory compliance, formulate action plans, and implement solutions.
• Ability to work effectively in a fast paced, rapidly changing environment and to work on multiple work streams and projects simultaneously.
• Bachelor’s Degree in Chemistry, Biology, Engineering, or related field.
• Minimum of 8 years professional working experience in the field of healthcare products or related activities such as pharmaceutical or device manufacturing, Quality Control or Quality Assurance including at least 4 years in GMP Quality or Compliance.

Nice To Haves

• Six sigma/lean processing, project management professional and/or auditor certification preferred.

Responsibilities

• Responsible for autonomously executing activities associated with the RDQ framework of audit and inspection management, inspection readiness, gap assessments, risk management and incident escalation.
• Partners with RDQ to develop plans for R&D audit programs and inspection preparation to minimize critical observations and ensure Takeda’s regulatory reputation remains positive with global authorities.
• Responsible for the implementation of Risk Management principles across RDQ, ensuring consistency of approach and compliance to SOPs.
• Responsible for authoring, editing, and circulating for approval the associated family of documents.
• Ensure the execution of the RDQ Regulatory Intelligence program, reviewing, documenting and gap assessing global regulatory changes across all GxPs (GMP, GCP, GDP, GLP, PV) used within R&D/R&D Quality to ensure continued compliance with current global regulations.
• Accountable for application of the gap assessment process, ensuring consistency of approach and compliance to SOPs.
• Responsible for identifying and executing on process improvements that are identified associated with the process.
• Steward the R&D Quality Management System, ensuring R&D and R&D Quality remain in compliance with Global GxP regulations in coordination with the R&D Quality Compliance team.
• Serve as system owner for centrally accessed QMS processes
• Advances R&D/RDQ-wide forums to increase awareness, foster cross-functional learning, and improve knowledge.
• Develops metrics, trending programs, and continuous improvement plans for processes and systems used across R&D/R&D Quality.
• Lead and independently execute projects which enhance RDQ’s efficiencies and innovation.
• Engages in global, enterprise-wide cross-functional projects and programs on behalf of RDQ.
• Provide subject matter expertise and consultation for R&D Compliance related to deviations, CAPAs, change controls, responses to inspection outcomes and incident escalations.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees