Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Local Operating Company (LOC) Medical Quality Assurance at our Cambridge, Massachusetts location (remote).
Here, you will be a vital contributor to our inspiring, bold mission.
In this role, you will contribute to Takeda’s mission by having the ability to lead effectively and work concurrently across multiple projects in a goal-oriented, timeline-driven, and dynamic work environment, while ensuring quality and accuracy. A typical day will include:
- This position has responsibility for the ongoing development and operational success of the LOC functions responsible for GCP- and GVP within assigned region. This includes alignment of LOC initiatives, goals and activities with R&D QA goals.
- Ensure local implementation of global standards and procedures.
- Supports regulatory inspections and partner audits of LOCs within assigned region.
- Consults with the Local Operating Company (LOC) functions responsible for clinical and post-marketing studies and pharmacovigilance activities to ensure the implementation of strategies regarding the processes, procedures, quality standards and vendor oversight required to maintain compliance with applicable regulations, e.g. PSMF requirements.
- Ensure that LOCs within assigned region are fully prepared for regulatory inspections of GCP- and GVP-regulated activities and provide on-site support and guidance during regulatory inspections.
- Provide direction and ensure inspection responses are timely and appropriate to maintain Takeda’s good standing with regulatory agencies.
- Conducts audits of LOC and/or local PV System Suppliers
- Oversees CAPA development, execution, closure and, as needed, escalation for CAPAs associated with stakeholder group.
- Ensures contract auditors are and/or maintain the appropriate qualifications.
- Remain current with industry trends and draft regulations/guidance.
- Works with contract owners to determine acceptability of Pharmacovigilance suppliers for potential use by Takeda, and provide ongoing direction, guidance and strategy for supplier oversight.
Knowledge and Skills:
- In-depth knowledge of the applicable GxP and GVP regulations and guidance and ICH Guidelines.
- Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
Clinical Development: Understands the phases, processes and techniques used to execute a clinical development program.
- Understands the medical/therapeutic impact of products.
- Possesses the necessary science education and knowledge to provide QA oversight of clinical trials and pharmacovigilance activities, and to assure ethical treatment of subjects. Understands medical terminology and is familiar with standards of care and disease states.
- Demonstrates strong leadership skill and the ability to influence others.
- Risk management expertise, including issue identification, problem solving, decision making, and risk mitigation.
- Demonstrates proficiency in negotiation and conflict resolution.
- Must professionally, clearly, concisely and consistently communicate to external and internal customers via phone, e-mail, fax, and written documents. Must also be able to demonstrate professional presentation skills deliver fair balanced presentations and, when applicable, facilitate resolution of differing opinions.
- Must demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
- Organizational skills: Must be able to prioritize work effectively to meet timelines.
- Interpersonal: Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
- Computer skills: Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members.
- Certified Quality Auditor, ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional preferred.
- Ability to drive to or fly to various meetings or LOCs, including overnight trips. Some international travel may be required.
- Requires frequent travel.
EDUCATION, EXPERIENCE AND SKILLS:
- Bachelor’s Degree required; Advanced Degree preferred.
- Minimum BS/BA degree with advanced scientific degree preferred.
- Minimum of 5 years of increasing responsibility in pharmaceutical, GCP- and/or GVP related Quality environment.
- In-depth knowledge of the applicable GVP/GCP regulations and ICH Guidelines.
WHAT TAKEDA CAN OFFER YOU
- Excellent conditions & benefits including generous holidays
- Genuine career progression and development
- Opportunity to work with a world class leader in the pharmaceutical sector
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.
Empowering Our People to Shine
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.