RDQCS Compliance Lead
- Employer
- Takeda
- Location
- Lexington, Massachusetts
- Start date
- Oct 26, 2024
View more categoriesView less categories
- Discipline
- Regulatory, Legal/Compliance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown, Best Places to Work
Job Details
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Job DescriptionJob Title: RDQCS Compliance Lead
Location: Cambridge, MA
About the role:Member of the global R&D Quality Compliance organization, providing cross functional expertise and strategic 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.
Provides key input to the establishment of the framework for quality oversight of the R&D Quality Management System.
Serves as a Quality Partner across R&D Quality.
Contributes to the design, implementation and advancement of the R&D Quality Management System operations.
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.
Ensures 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.
Stewards 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.
Leads and independently executes projects which enhance RDQ’s efficiencies and innovation. Engages in global, enterprise-wide cross-functional projects and programs on behalf of RDQ.
Provides subject matter expertise and consultation for R&D Compliance related to deviations, CAPAs, change controls, responses to inspection outcomes and incident escalations.
Bachelor’s Degree in Chemistry, Biology, Engineering, or related field.
Minimum of 10 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.
Six sigma/lean processing, project management professional and/or auditor certification preferred
Technical/Functional (Line) Expertise
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
Leadership
Demonstrated teamwork, initiative, and problem-solving skills
Clear, concise, and consistent in written and verbal communications
High attention to detail
Decision-making and Autonomy
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.
Interaction
Experience working within complex/matrixed organizations
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
Innovation
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
Complexity
Analytical capabilities with the ability to analyze a wide variety of information and data to determine potential risks
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
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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.
#GMSGQ #ZR1 #LI-MA1
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MAU.S. Base Salary Range:
149,100.00 - 234,300.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-termincentives. 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.
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.
LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
YesCompany
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation. Today, our organization spans the globe—colleagues across business units and functions face challenges head-on to deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
As a values-based, R&D-driven biopharmaceutical leader headquartered in Japan, we focus our R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. In addition to our R&D efforts, we’re laser-focused on harnessing the power of data, digital, and technology to improve health outcomes for patients across the globe.
Since our founding in Japan, integrity and putting patients first have been at the heart of our identity. We're proud of our employees and their commitment to improving the quality of life for patients, and to working with our partners in health care in approximately 80 countries and regions. With each new breakthrough comes opportunities to develop your career, hone new skills, and create a brighter future
For more information, visit https://jobs.takeda.com/
- Website
- https://www.takeda.com/
- Location
-
650 East Kendall Street
Cambridge
MA
02421
United States
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