Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager, Local Operating Company (LOC) Medical Quality Assurance in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager working on the R&D Quality Assurance team, you will be empowered to execute the LOC audit strategy as determined by the department Head, and a typical day will include:
- Works with applicable team (s) to ensure local implementation of global standards and procedures.
- Supports regulatory inspections and partner audits of LOCs within assigned region.
- Supports LOC MQA team members and 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.
- Assists LOCs within assigned region to be fully prepared for regulatory inspections of GCP- and GVP-regulated activities and provide on-site support and guidance during regulatory inspections.
- 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.
- Works with LOCs within assigned area to obtain information necessary for the Pharmacovigilance System Master File (PSMF)
- 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.
EDUCATION, EXPERIENCE AND SKILLS:
- Bachelor s Degree required; Advanced Degree preferred.
- Minimum BS/BA degree with advanced scientific degree preferred.
- Minimum of 3 years of industry experience in Quality Assurance with focus in GVPs and GCPs:
- In-depth knowledge of the applicable GVP/GCP regulations and ICH Guidelines.
- Minimum of 3 years of increasing responsibility in pharmaceutical, GCP- and/or GVP related Quality environment.
Knowledge and Skills:
- In-depth knowledge of the applicable GCP 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.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to drive to or fly to various meetings or LOCs, including overnight trips. Some international travel may be required.
- Requires frequent travel.
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
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.