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 an Internal & Supplier Audit Lead (Associate Director) in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Internal & Supplier Audit Lead (Associate Director) working on the R&D Quality team, you will be empowered to coordinate the execution of the overall Internal Suppler Audit strategy and R&D QA & Compliance (QA&C) Operational objectives, and a typical day will include:
Primary responsibilities of this position are to:
Provide professional expertise and strong leadership in applicable guidance and regulations, proactively identifying potential areas of non-compliance and risk for assigned areas.
Execute Internal Supplier Audit strategy at the direction of the Head of Internal & Supplier Audits
Serve as a QA & Compliance Liaison for Preferred Providers Governance Councils or internal committees, as assigned
Provide Compliance & Management Support for identified issues arising with supported R&D Business areas, and for other QA & Compliance project initiatives
Provide support for QA & Compliance Regulatory Agency Inspections
- Liaise and network with internal and external business partners to implement ISA strategy
- Lead the planning, execution and close out of assigned ISA audits
- Lead ISA driven CAPAs, effectiveness checks, and issue escalation, as assigned
- Designated auditor/co-auditor for assigned ISA audits
- Lead ISA facilitated meetings.
- Participate in QA&C project initiatives (System Development and COE driven)
QA&C Liaison for Preferred Provider(s)
- Liaise and network with internal and external business partners to provide guidance and support pertaining to compliance/quality oversight initiatives
- Prepare and lead or support governance council meetings
- Facilitate issue escalation and oversight of remediation as appropriate
- Manage preferred provider partnership as assigned
Internal Supplier & Audits and QA & Compliance Support
- Liaise and network with internal and external business partners to implement ISA and QA&C initiatives
- Lead and/or support the planning, execution and close out of assigned ISA and QA&C initiatives
- Provide compliance guidance and support for R&D as appropriate
- Provide support to management as requested
Regulatory Agency Support
- Support, as needed, the preparation, conduct follow-up/responding, and lessons learned to GXP inspections
Education and Experience Requirements
Bachelor s degree in a life science or equivalent experience; Graduate degree in a scientific discipline or program management a plus
Minimum of 8 years of pharmaceutical experience, including international experience
Ideal candidate will have broad experience in product development, regulatory compliance, supplier management, GxP auditing and at least 3 years of direct or matrix management experience.
Key Skills, Abilities, and Competencies
Extensive knowledge and/or awareness of local and international regulations. Maintains awareness of newly published regulations.
Strong understanding of the: drug development processes, clinical development operations, vendor outsourcing and procurement processes, regulatory affairs, GXP and internal process auditing
Collaborative team player who has the ability to think and act quickly and identify creative solutions to complex problems
Robust technical writing skills. Ability to write briefing documents, quality positions, audit reports and SOPs.
Strong attention to detail with the ability to articulate quality related risks and potential impact.
Leadership skills, and ability to inspire colleagues
Ability to take a big-picture approach to decision-making while taking account of the broad interests of Shire.
Strong project management and decision-making skills
A self-starter, who motivates, has tact and diplomacy and is able to define and prioritize tasks within a project
Excellent communication and interpersonal skills.
Demonstrates ability to manage global staff/activities
Ability to foster and balance a culture of compliance within a culture of innovation
Ability to influence without authority, in a matrix environment
Proficient knowledge of MS Word, Excel, PowerPoint & Outlook; working knowledge of Access, Trackwise a plus.
Complexity and Problem Solving
Exerts influence in the development of overall objectives and long-range goals of the organization.
Acts as an advisor to meet schedules or resolve technical or operational problems
Directly participates in establishing and administering centralized functional projects
Works on complex problems requiring analysis of situations or data and in-depth analysis of factors
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Internal and External Contacts
Interacts across R&D QA & Compliance and R&D Business Partners
Other Job Requirements
Domestic and international travel may be required per business need.
Must have a global mindset.
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.