Director Quality Surveillance
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 a Director Quality Surveillance in our Cambridge. MA Location office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As the Director of Quality Surveillance working on the GQ Oncology & Biologics team, you will be empowered to deliver high quality products to our patients, and a typical day will include:
The Director of Quality Surveillance is responsible to lead the Complaint Process for Oncology and Biologics (O&B), ensuring site engagement and related department support of processes; Strong leadership to assure compliance and sustainable timeliness of overall Complaint Investigations- especially with regards to Regulatory reporting requirements.
- Drive development and lead implementation of efficient processes to assure sustainable compliance for complaints that enable improvement in patient / consumer complaint rates,
- The Director role interacts with Quality Assurance, Regulatory CMC, Supply Operations, Technical Operations, Pharmacovigilance, External Supply, IT Quality, Corporate Quality Compliance and Systems functions, LOCs, domestic and international Contract Manufacturing Organizations (CMOs).
- This position ensures that the O&B complaints program meet all FDA and Global affiliate GMP as well as other Global regulatory agency requirements for the markets TBOS manages,
including but not limited to US, EU, Japan, UK, Canada and ROW.
- This position also leads external engagement activities to promote Takeda as a top 10 biopharmaceutical company. Engages and monitor global external landscape utilizing technical expertise to assure compliance with external Regulatory and Quality Compliance trends and events.
- Provides leadership and guidance on the coordination of engagement and messaging at important Regulatory and Quality events and symposia. Monitors global GMP trends to help safeguard compliance in plants (no major recall, no warning letters)
- The Director creates a clear vision for the quality surveillance area to assure patient safety and company reputation, while serving as an expert in current and emerging regulatory requirements and industry best practices.
- Directs continuous improvement to ensure programs remain compliant with FDA and other regulatory requirements.
- Develops and maintains a broad network of relationships within the local and global environment. Represents the company at corporate and regional meetings and, as necessary, with Regulatory Agencies, industry groups and business partners.
- Demonstrate leadership and ability to focus efforts to work effectively in a fast-paced rapid changing environment and to work on multiple work streams and projects simultaneously
- Excellent organization, written, and verbal skills to convey goals and inspire support from both subordinates and senior management
- Directs the Commercial Product Complaint Program for all products
- Leads the complaints management team to work cross-functionally with other departments, Alliance Partners and Takeda Affiliates to ensure thorough investigation plans are developed and executed for timely and compliant closure of product complaints.
- Ensures appropriate systems are in place for Product Complaint handling including proper channels of communication and clear roles and responsibilities.
- Develop and sustain on-time Customer Complaint performance
- Creates, lead, and drive sustainability of proactive programs to ensure a state of control in completing investigations
- Responsible for timely escalation to management of any complaint issues that may represent potential quality or regulatory actions.
- Responsible for timely review and approval of Complaint related sections on the Annual Product Review.
- Assure appropriate Quality input and linkage between Product Quality complaints and Adverse Event Reporting
- Responsible for the alignment of Complaint related procedures with applicable Takeda s Global Standards and regulatory expectations for all applicable markets.
- Lead Product Complaint system discussions during regulatory inspections
- Ensures representation at weekly Case Review Meetings and Signaling Meetings, providing input on behalf of Commercial Quality Operations
- Provide annual goals, learning plan(s), and development plan(s) for employee(s)
- Oversees, Analyses and provide recommendations for Track and trending of complaints by product.
- Representative of Surveillance area in local and regional quality council.
- Identify and propose Quality process and system improvements. Lead improvement projects.
- Directs the external liaison and surveillance programs including
- Direct the establishment of processes to assure ongoing compliance with external requirements and current events/trends; Includes networking across internal organizations as well as external collaborations
- Responsible for defining and supporting ongoing sustainable global process review and updates of Compendial Change process;
- Submit proposals to Corporate oversee internal updates;
- Assure O&B GMSGQ network is aware and acts on changes to Compendia
- Drive process for strategic submissions to enhance O&B product superiority
- Drive in conjunction with Agile, continuous improvement (CIP) culture across all O&B areas
- Develop expertise to interpret and convert data from global external observations, commitments, and escalation issues into action items for systemic improvements, regarding O&B Quality systems
- Strong focus on developing local resources and capabilities of O&B organization through surveillance knowledge sharing
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- BA/BS with 15+ years Quality Systems / Compliance experience in the pharmaceutical/biotech/medical device industries or Master s Degree with 10+ years relevant experience in the pharmaceutical/biotech/medical device industries.
- Steadily increasing managerial experience and responsibility 10+ years combined with strong technical operations background.
- Proven performance of working knowledge of Global Complaint programs
- Working knowledge of global Compendial Processes
- Demonstrated experience in leading global change by influence
- Experience in pharmaceutical operations, supply chain management, Quality, project management and from working in an international environment
- Strong focus on delivering results as well as services
- Extensive global pharmaceutical industry knowledge
- Ability to handle multiple tasks concurrently, and in a timely fashion.
- Must be able to communicate effectively with employees, peers and management.
- Leadership and solid knowledge of Global Quality Risk management
- Deep knowledge of ICH activities (esp. Q8,Q9, Q10, Q11)
- Must be able to read, write and converse in English.
- Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
- Excellent interpersonal skills and can work effectively and efficiently in a team environment.
- Excellent presentation skills and able to lead discussions at all levels of the organization
- Must display eagerness to learn and continuously improve.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
Wrist and hand motion (e.g. typing, writing)
- Willingness to travel to various meetings, including overnight trips. Some international travel may be required.
- Potential international or domestic travel, up to approximately 20%.
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.