Quality Auditing Services Manager -Remote応募後で応募 求人ID R0024876 掲載日 05/07/2021 Location:Boston, Massachusetts; Konstanz, Germany
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Auditing Service Manager who is bilingual skills with English and French or German, is highly desired. Due to the global auditing schedule demands of the role, it is remote and the candidate can be located from in a European county, for example: Austria, Germany, Switzerland, Italy, or in the US in Boston, Massachusetts.
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.
Here, you will be a vital contributor to our inspiring, bold mission.
- Execute direction and governance to sites, operating units and functions for self inspection and internal auditing processes
- Implement risk based approach to the auditing program underpinned by PTRB
- Complete tasks associated Business Process ownership of audit management systems and processes, Business Development & Due Diligence, Auditing Risk Assessment, Project Management, Quality audits of GMS and LOCs, Audit Planning/ Monitoring/ Reporting, and/ or Inspection readiness.
- May be a Key Contact for Operating units for auditing activities and services
- Implement and execute audit activities within Takeda which focuses on a risk based approach to self inspection and auditing which identifies and resolves risks
- Execute unified and shared audit services platform throughout Takeda to enable consistent and effective audit operations and Due Diligence audit support activities worldwide
- Carry-out strategic direction and provide oversight pertaining to auditing which achieves sustained success for regulatory inspections and supply chain product quality
- Enact global audit policies, guidance, standards, procedures governing self inspection, risk identification and auditing
- Execute duties associated with one or more of the following:
- Business Process ownership of audit management systems and processes
- Business Development & Due Diligence: provide subject matter expertise to enable decision making; identifying quality related risks to projects and the provision of appropriate resolutions
- Auditing Risk Assessment: further develop and deploy risk assessment program
- Project Management: Oversee Project Management activities within the group including visibility, tracking, implementation and governance through change and project management
- Quality audits of GMS, LOCs, and/or suppliers
- Audit Planning/ Monitoring/ Reporting: coordinate global audit planning / scheduling to assign lead auditors and co-auditors within region to perform audits according to annual (fiscal year) audit plan by working with Site QA auditors, Supplier Quality management and Internal auditors.
- Inspection readiness: develop and deploy an inspection readiness program for activities at a site, regional and global level
- May require up to 50% travel
- Other duties as assigned
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise:
- Knowledge and experience of Bio-Pharmaceutical, R&D and/ or Vaccines Manufacturing
- Knowledge and understanding of therapeutic areas as well as scientific advances and modalities for treating diseases.
- Knowledge and understanding of relevant regulations enabling effective partnerships across the organization
- Ability to lead the quality audit teams and support projects across Quality Auditing and Supplier Quality
- Tactical role to help develop, deploy and govern the quality auditing processes and tools to sites / regions and global function
Decision-making and Autonomy:
- A member of the Quality Auditing and Services team
- Responsible for risk identification for internal sites and operating units and resolution of incidents
- Align and partner with Quality Auditing & Supplier Quality regarding execution of responsibilities
- Partner with Operating units to support business priorities from an audit perspective
- Communicate and train sites, operating units and global functions regarding audit management and self-inspections
- A firm grasp of industry, scientific and regulatory trends, understands market conditions, and leverages innovation to evolve Takeda’s regulatory profile to become the model for the industry
The complexity in the role lies in the diversity of manufacturing techniques and facilities as the role covers all geographies and therapeutic areas
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Scientific degree (BSc, MSc)
- 8+ years of increasing management responsibility combined with knowledge of pharmaceutical manufacturing
- Experience across all of the Quality pillars (QA, QC, Systems and Compliance, Services and Improvement) and working in an international environment
- Effective finance and controlling knowledge and competencies to manage mid-range organization
- Fluent in written and spoken English and French or English and German- is highly desired!
Core Competencies / Skills
- Critical Thinking
- Current on local and global regulations
- Digital and analytical skills
- Investigation and problem solving
- Strong communication skills engaging stakeholders: site, business, network, company, regulators
- Risk identification, evaluation and management
- Continuous improvement
- Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust
- Creating the environment that inspires and enables people
- Focusing on the few priorities and provide superior results
- Elevating capabilities for now and the future
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
This job posting excludes CO applicants.
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.