Takeda is a global, innovation-driven pharmaceutical leader with 30,000
professionals working together across more than 70 countries. We have an
unwavering dedication to put patients first for more than 230 years while we
live our values of Takeda-ism Integrity, Fairness, Honesty, and
Perseverance. We are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading
innovation in medicine.
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. A
typical day will include:
- Engaging cross-functional, cross-company
and cross-partner matrixed response teams to respond to high risk, high impact
- 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 are also a core
responsibility of this role.
- 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 AD 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.
- Lead Regulatory notification and recall
programs for Takeda Pharmaceutical USA, including actual event communication
and follow up, and recall readiness exercises to manage risk in our dynamic and
complex environment of new products and therapies, global supply chains and
- 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 each business change, including acquisitions,
product launches, new business partners and new customer bases to ensure
continued compliance and clear business process.
- Ensure alignment of PV and product
complaint management systems through effective process and technology design
and management, and effective collaboration with internal and external
- 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
- Lead multidisciplinary, cross-functional
and cross-business teams to create strategies for risk assessment and
mitigation. Oversee execution of plans
- 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
- Manage staff, vendors and business partner
relationships for 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 associated with product
complaints, the FDA Drug Quality Reporting System, Field Alerts or
BEHAVIORAL COMPETENCIES AND SKILLS:
- Minimum 12 years experience
in pharmaceutical QA/QC or equivalent
- Bachelors degree in life
sciences, i.e., biology, chemistry, etc.
- 6 years leadership/people
- Expertise in cGMPs and other
- Project management expertise
- 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%
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
Our People to Shine
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
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