|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 Associate Director, Internal Audits and Inspection Management in our Cambridge office.|
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As anAssociate Director working on the Internal Audits and Inspection Management team, you will be empowered to lead a unique combination of internal audits and inspection readiness, and a typical day will include:
- Under the guidance of the leader of Quality Surveillance, provide leadership and communication of the strategic direction for regulatory inspection readiness and the internal audit program in R&D. This role partners with the functional groups in R&D and R&D Quality.
- Drives activities to manage regulatory inspection and internal auditprograms in R&D.
- Provides regulatory and technical expertise to manage the regulatory inspection, internal audit programs and the continuous improvement.
- Manage the global quality professionals responsible for the regulatory inspection and the internal audit.
- Provides leadership and strategic direction for regulatory inspection readiness and internal audit program in R&D.
- Works closely with the functional areas in R&D and key stakeholders in R&D Quality to prepare for and manage regulatory inspections and to evaluate risk when determining the internal audit schedule.
- Drives activities for the regulatory inspection management activities.
- Drives activities for the internal audit execution, including ensuring the selection of appropriately trained auditors, timely conduct and clear and concise documentation of audit findings, and clear and proactive communication with stakeholders throughout the internal audit process.
- Provides the oversight for the completion of CAPAs from the regulatory inspections and the internal audits, and drives the on-time completion of CAPA commitments.
- Provides regular reports to R&D Quality leadership on the status of the regulatory inspection readiness and the internal audit program and CAPA commitments.
- Serves as a strategic thought partner to the Head of R&D Quality Surveillance with regard to complex problems and the future strategies of regulatory inspection management and internal audit management in R&D.
- Manage the global Quality professionals responsible for the regulatory inspection and the internal audit.
- Ensure alignment with the Global Quality Auditing function for regulatory inspection management and internal audit as appropriate.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor s Degree in Chemistry, Biology, Engineering or related field. Masters preferred.
- Minimum 8 years of Quality/QC/Compliance experience.
- In-depth understanding of global regulations governing the US and international pharmaceutical industries. Ability to translate and articulate appropriate strategies and activities to ensure compliance to all regulations relative to quality management systems.
- Experience working within complex organizations, working closely with senior staff and executives level colleagues.
- Experience in identifying and implementing organization-wide compliance initiatives.
- Ability to influence and work effectively with various business partnerships, regions and cultures.
- Strong interpersonal skills particularly motivational, negotiation, listening, judgment, and conflict management skills, demonstrated by ability to lead teams in a complex, matrixed and global environment.
- Excellent organization, verbal and written communication skills to explain project goals and inspire support.
- Ability to work well with cross-functional teams to accomplish objectives. Ability to work effectively in a fast paced, rapidly changing technology environment, and to work on multiple work streams and projects simultaneously.
- Demonstrated analytical capabilities with the ability to analyze a wide variety of information and data to make management decisions regarding potential risks associated with regulatory compliance.
- Demonstrated ability to anticipate potential problems and risks related to quality system expectations and regulatory compliance, formulate action plans, and implement solutions
- Must have an advanced knowledge and understanding of the drug development process, scientific methods and thought processes, specifically the manufacturing process, to ensure regulatory compliance information is up-to-date.
- Approximately 50% domestic and international travel.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.