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 of Quality Compliance in our Deerfield, IL office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director of Quality Compliance working on the Compliance team, you will be empowered to listen to the patients and ensure the integrity of Takeda s products and mission to put patients first and a typical day will include:
- Engaging cross-functional, cross-company and cross-partner matrixed response teams to respond to high risk, high impact issues.
- The Associate Director of Quality Compliance will be responsible for creating a clear and unifying vision for the quality compliance area to assure product and process compliance.
- Strategic design and leadership of the quality compliance function for Takeda Pharmaceutical USA, through implementation of necessary compliance strategies, quality plans and the development and oversight of compliance site programs..
- These programs include site quality council, regulatory support and inspection functions, site metrics and corrective action oversight, product quality communications and the management of customer complaints to mitigate risk and avoid risk of harm to patients, negative regulatory exposure and/or adverse impact to the business.
- The Associate Director of Quality Control will also establish and implement effective Complaint Investigation programs, addressing risk identification, elevation and monitoring to assure that critical issues are quickly surfaced, understood and resolved. As required, works with other Takeda manufacturing facilities and/or outside vendors, including packagers, manufacturers and suppliers as part of complaint resolution.
- Leads Regulatory notification and recall programs for Takeda Pharmaceutical USA, including actual event communication and follow up.Also leads recall readiness exercises to help identify and manage risk in our dynamic and complex environment of new products and therapies, global supply chains and business partners.
- Independently and directly represent Takeda Pharmaceuticals, USA Quality to make decisions on complaint program design with business/marketing partners, affiliates, Global Pharmacovigilance and Global Medical Affairs resulting from business changes, including acquisitions, product launches, new business partners and new customer base to ensure continued compliance and clear business process.
- Ensure alignment of Pharmacovigilance and product complaint management systems through effective process and technology design and management, and effective collaboration with internal and external partners.
- Establish strategic requirements for enhancement of IT systems/technology platforms for complaint information management and data analysis to enable timely risk identification and to assure regulatory compliance.
- Lead multidisciplinary, cross-functional and cross-business teams to create strategies for risk assessment and mitigation. Oversee execution of plans and resolution.
- Manage internal site management notification programs to ensure consistent and accurate messaging. Evaluates and provides improvements to other communications and communication tools to appropriately provide compliance information to other parts of Takeda USA and global partners
- Manage staff, vendors and business partner relationships to assure compliance with cGMPs, Takeda Quality System expectations and contractual obligations.
- Represent Takeda Pharmaceuticals USA (TPUSA) Quality during FDA or other regulatory inspections of TPUSA, Takeda (Pharmacovigilance audits) or third party vendors audits.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Minimum 12 years experience in pharmaceutical QA/QC or equivalent with six (6) years leadership/people management experience.
- Bachelors degree in life sciences, i.e., biology, chemistry, etc.Expertise in cGMPs and other pertinent regulations
- Creates a positive and motivating work environment with the ability to know what motivates different people and aligns work accordingly.
- Demonstrated ability to communicate ideas and data both verbal and written in a persuasive and appropriate manner
- Demonstrated ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
- Demonstrated ability to effectively lead and motivate a team of direct reports, provide unifying vision, build on strengths and address areas of improvement.
- Demonstrated ability to anticipate potential problems and risks related to commercial product operations, investigate solutions and implement preventive actions.
- Demonstrated ability to focus on the highest priorities, laying out a thorough schedule and steps for achieving objectives, without losing sight of les critical longer term objectives.
- ASQ or other quality or regulatory certification programs preferred.
- Willingness to travel to various meetings, suppliers, vendors or manufacturing sites, including overnight trips. Some international travel may be required.
- Requires approximately 10% 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 takedajobs.com.
No Phone Calls or Recruiters Please.