BostonRecruiter Since 2001
the smart solution for Boston jobs

Manager, Local Operating Company Medical Quality Assurance

Company: Takeda
Location: Cambridge
Posted on: December 5, 2019

Job Description:

I understand that my employment application process with Takeda will commence and that I agree with Takeda s Privacy Notice, Privacy Policy and Terms of Use. Job_Description 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. Objective 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. Accountabilities * 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 EDUCATION, EXPERIENCE AND SKILLS: * Bachelor s Degree required; Advanced Degree preferred. Experience * 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. Licenses/Certifications * Certified Quality Auditor, ASQ Certified Manager of Quality/ Organizational Excellence, or SQA Registered Quality Assurance Professional preferred. Physical_Demands * Manual dexterity required to operate office equipment (i.e. computers, phones, etc.). * Carrying, handling and reaching for objects. Travel_Requirements * 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 **************. No Phone Calls or Recruiters Please. Locations Cambridge, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda, Boston , Manager, Local Operating Company Medical Quality Assurance, Executive , Cambridge, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Assistant Director
Description: Description: br br KinderCare Education is the nation's leader in early childhood education. We nourish curiosity through purposeful experiences to create a future full of lifelong learners. From (more...)
Company: KinderCare Education
Location: Somerville
Posted on: 12/13/2019

Art Director
Description: ART DIRECTOR Superdigital is a creative ad agency located on Commonwealth Avenue in Boston. Our clients range from food and CPG to restaurants, luxury real estate to sports, including Julian Edelman of (more...)
Company: Superdigital
Location: Boston
Posted on: 12/13/2019

Associate Director, Data Science
Description: DescriptionThe Associate Director, Data Science uses mathematics, statistics, modeling, business analysis, and technology to transform high volumes of complex data into advanced analytic solutions. The (more...)
Company: Humana
Location: Boston
Posted on: 12/13/2019

Global Account Manager
Description: Medidata: Conquering Diseases Together br br Medidata is leading the digital transformation of life sciences with the world's most-used platform for clinical development, commercial and real-world (more...)
Company: Medidata Solutions
Location: Boston
Posted on: 12/13/2019

Care Integrity & Quality Assurance Program Manager
Description: OVERVIEW br br Under general supervision, the Program Manager of Care Integrity and Quality Assurance is responsible for the development, planning, coordination, and execution of a strategic plan (more...)
Company: Commonwealth Care Alliance
Location: Boston
Posted on: 12/13/2019

Executive Asst CNO VP
Description: Executive Asst CNO VP Department Patient Services-Nursing AutoReqId 53592BR Status Full-Time Standard Hours per Week 40 QuestionType Job Posting Description At Boston Childrens Hospital, success is (more...)
Company: Boston Children's Hospital
Location: Boston
Posted on: 12/13/2019

Unit Supply Specialist - Warehouse Manager (92Y)
Description: 92Y Unit Supply Specialist - Warehouse Manager Job ID: 1163003 Job Views: 27 Location: FRAMINGHAM, Massachusetts, United States ZIP Code: 01702 Job Category: Supply and Logistics Posted: 12.06.2019 Age (more...)
Company: Army National Guard
Location: Framingham
Posted on: 12/13/2019

Director of Advancement
Description: Job Description Important Note: During
Company: Wells Fargo
Location: Cambridge
Posted on: 12/13/2019

Cyber Business Development Professional - Director
Description: Overview:What do you get when you bring together the brightest minds and place them into an exciting, fast-paced environment that fosters intellectual growth and rewards based on impact, not tenure You (more...)
Company: Guidehouse
Location: Holbrook
Posted on: 12/13/2019

Branch Manager, Northern, MA/NH Area (Float), Methuen, MA
Description: Branch Manager, Northern, MA x2F NH Area Float , Methuen, MA-1906159DescriptionAs a member of Santander------s retail banking division you------ll help serve Santander------s retail and small business (more...)
Company: Santander
Location: Acton
Posted on: 12/13/2019

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Boston RSS job feeds