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
- 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..
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
- 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
- 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 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
- Minimum 12 years experience in
pharmaceutical QA/QC or equivalent with six (6) years leadership/people
- 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
- 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
- Tuition reimbursement Company match of charitable
- 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
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