|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, Inspection Management in our Cambridge office.|
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director working on the Inspection Management team, you will be empowered to lead inspection readiness strategies, and a typical day will include:
- Under the guidance of the Head of R&D Quality Compliance, lead health authority inspection readiness activities, and manage health authority inspections. This role partners with the functional groups in R&D and R&D Quality.
- Drives activities to ensure a state of readiness for health authority inspections within R&D.
- Provides regulatory and technical expertise to manage the regulatory inspection preparation and execution processes, including development of any related continuous improvement opportunities.
- Manage the global quality professionals responsible for regulatory inspection.
- Develops processes to prepare for and manage health authority inspections, and leads health authority inspection preparation and management activities.
- Identifies and engages key Subject Matter Experts from R&D and R&D Quality to participate in inspection readiness and management activities.
- Evaluates all proposed commitments to health authorities in response to inspection findings. Ensures that all commitments are met on time via tracking CAPAs and ensuring their timely closure.
- Provides regular reports to R&D Quality leadership on the status of the regulatory inspection readiness and CAPA commitments.
- Serves as a strategic thought partner to the Head of R&D Quality Compliancewith regard to complex problems and the future strategies of health authority inspection management in R&D.
- Manage the global Quality professionals responsible for health authority inspections.
- Evaluates outcomes of health authority inspections and conducts lessons learned sessions to ensure the process improvements are implemented.
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 35% 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.