Job Title: Biologics and Plasma Complaints Specialist
Location: Lexington, MA
About the role:
Responsible for managing the complaints mailbox and input sources and writing product quality complaints and all related activities associated with the complaint handling program at Takeda per corporate procedure and regulatory standards including goal setting in-line with corporate strategy and priorities and the GQ road map.
The scope of responsibility encompasses timely management of the complaint processes to comply with corporate procedures, EU and FDA regulations, ISO13485 and other regulatory requirements as applicable. Escalate and participate in resolution of potential product deficiencies for all applicable Takeda products originating from a market complaint. Liaise with Internal Stakeholders, Call Centers and service providers to ensure they support Takeda's corporate policies and guidance while aligning with all of the necessary regulations and standards. Serve as the Quality liaison between individuals and business units within or outside the organization regarding matters related to product complaint activities, including risk management, regulatory inspections and complaint handling processes for all applicable products. Identify and drive continuous improvement to ensure a lean and compliant process.
How you will contribute:
- Managing the complaints mailbox
- Serve as point of contact for commercial & clinical product complaints and post market product vigilant monitoring processes
- Receive, initiate, investigate and conclude product complaint investigations using the current product complaints management software and coordinate all aspects of investigation through closure and/or provide oversight for complaint handling process.
- Apply departmental procedures to assess product complaints' impact on patient safety and product quality compliance.
- Assess product complaints and determine if escalation is required due to potential regulatory notification requirements.
- Interface and collaborate with various departments including the OpUs, External Supply, Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance, etc and the regional organization. Interface with external stakeholders such as CMO, Call Centres and vendors/contractors on product complaint issues.
- Assure that all product complaints are investigated to the appropriate level within the required timeline.
- Send customer response/mailbox responses.
- Drive continuous Improvement to ensure a lean and compliant process
Technical/Functional (Line) Expertise
Subject Matter Expertise in assigned product platform (Biologics and Plasma) and a strong working knowledge of the complaints process or multiple pharmaceutical quality management systems.
Clear communicator, ability to distil complex information into clear and concise key points and make recommendations regarding necessary course of action. Ability to listen and understand different functional needs and perspectives, and influence others. Positive and accountable change agent, with ability to formulate and execute vision and create a culture of continuous improvement. Organized with excellent time management.
Decision-making and Autonomy
Accountable and empowered leader for all operational decisions relating to complaint management with sound and timely decision-making using available information and based on the complexity and impact of decisions, will consult or inform relevant stakeholders and escalate if necessary.
Interacts with senior Quality, GMS leadership, cross functional teams as well all external parties relevant to complaint management. Acts as primary liaison with regulatory agencies in terms of quality complaint management. Ability to build strong collaborative working relations across the OpUs and regions.
Technical expertise to support the management, development and evolution of the product complaint process.
Ability to operate in an internal and external business environment globally, across many different cultural considerations and complex regulatory frameworks.
What you bring to Takeda:
- Bachelor's degree with a minimum of 3-6 years of experience in Quality Assurance or a GMP related field within Medical device, biotechnology or pharmaceutical manufacturing.
- Working knowledge of cGMPs and other regulatory requirements governing combination drugs and device products.
- Knowledge of EU/ FDA cGMP requirements pertaining to drug/device product complaints reporting and investigation.
- Desirable experiences: combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits.
- Good understanding of the manufacture of combination products and the linkage to customer complaints.
- Strong attention to detail, good organizational skills and well-structured.
- Has a systematic way of working, prioritizing tasks based on risk or criticality - seeking effective solutions within the complexity that surrounds product complaints.
- Excellent troubleshooting and problem-solving skills.
- Skill in writing investigation summaries and complaint responses.
- Independent, organized and able to schedule work without supervision to meet schedule deadlines.
- Ability to work independently as well be an effective team member and leader.
- Approachable and possess the ability to forge solid working relationships with colleagues across all functions, its partners and contractors.
What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- 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 and company match of charitable contributions
- Family Planning Support
- Professional training and development opportunities
- Tuition reimbursement
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
- Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This posting excludes Colorado applicants.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.