Head, Good Pharmacovigilance Practices Inspection Readiness (Upper Marlboro)

Employment Type

: Full-Time


: Information Technology

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Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takedas long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole. As one of the worlds leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units. We are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us! What makes a successful member of our team? Check out the traits were looking for and see if you have the right mix. Recognized for our culture and way of working, were one of only select companies to receive Top Global Employer status for 2019. Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we dofrom decision-making to interacting with patients. Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work. A strong, borderless team, we strive together towards our priorities and inspiring mission. Recognized for our culture and way of working, were one of only 13 companies to receive Top Global Employer status for 2018. 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 Head, GVP Inspection Readiness in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director working on the Global Patient Safety Evaluation Quality Assurance team, you will be empowered to lead inspection readiness activities, enabling proactive inspection readiness across the entire PV System and support inspections where GSPE is a stakeholder, and a typical day will include: OBJECTIVE: Drives the inspection strategy for the PV System, using the framework provided by R&D Quality Compliance and Systems and assures inspection planning across PV System enabling ongoing efforts to maintain a steady state of inspection readiness. Engages senior leadership to enable execution of the plan. Identifies risks within the PV System and drives mitigation/remediation activities. Develop strategy for hosting on site business partner audits, leveraging experiences to improve on inspection readiness activities. Clear understanding of Takedas inspection risk Reports to the Head of GPSE QA and serve as a member of the GPSE QA Leadership Team (GPSE QA LT). ACCOUNTABILITIES: Provides leadership for the GPSE QA Inspection readiness organization, cascading messages and goals from senior management, managing & prioritizing team workload, managing team performance Lead inspection response activities ensuring a Quality Contact is assigned for CAPAs owned by stakeholders Develop strategy to understand health of the PV System, e.g. risk register, KPIs Partner with R&D Quality Compliance and Systems and stakeholders for internal audits related to PV System Host audits conducted on site from business partners Take a leadership role during inspections to organize site departments, coach subject matter experts, or interface with inspectors. EDUCATION, EXPERIENCE AND SKILLS: Education & Experience Bachelors Degree required; Advanced Degree preferred. Minimum 12 years of increasing responsibility in pharmaceutical, GCP- and/or GVP related Quality environment. Minimum 10 years of people and/or process management experience in GCP and/or GVP Quality Assurance including senior level project planning/budget management. Minimum 8 years of progressive matrix management experience, and extensive experience leading a team dispersed in multiple, global locations. Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives Skilled in managing global, cross-functional projects Skills/Knowledge: Regulatory Knowledge - Expert knowledge of global GCP and GVP regulations and guidances; good working knowledge of global GMP and GLP regulations and guidances. Understands the regulatory environment for global pharmaceutical companies, as well as best practices in the Pharma industry to satisfy regulatory requirements. Industry Knowledge Strong working knowledge of the pharmaceutical industry and the new drug development process; understands the phases, processes and techniques used to execute a clinical development program. Demonstrates advanced knowledge in the conduct and reporting of audits and investigations, as well as the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity. In-depth understanding of the good practices for the creation and management of a Quality Management System. Scientific Knowledge - Possesses the necessary science education and knowledge to provide Quality Assurance oversight of clinical trials and to assure ethical treatment of subjects. Understands medical terminology and is familiar with standards of care and disease states. Communication Skills - Must professionally, clearly, concisely and consistently communicate to external and internal customers, both verbally and in writing. Must demonstrate professional presentation skills. Negotiation Skills - Demonstrates proficiency in negotiation and conflict resolution. Personnel Management Knowledge Proficient in managing large teams, and in providing coaching and mentoring to employees. Project Management - Demonstrates proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines. Organizational Skills - Must be able to prioritize work effectively to meet timelines, and delegate to subordinates. Interpersonal - Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building. Computer skills - Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members. LICENSES/CERTIFICATIONS: ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional or equivalent preferred. Six Sigma Green Belt or Black Belt preferred. PHYSICAL DEMANDS: Manual dexterity required to operate office equipment (i.e. computers, phones, etc.). Carrying, handling and reaching for objects. TRAVEL REQUIREMENTS: Position is located in Boston. Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel will be required. Search for a category and select one from the list of suggestions. Search for a location and select one from the list of suggestions. Finally, click Add to create your job alert. By submitting your information, you acknowledge that you have read our privacy policy and consent to receive email communication from Takeda Pharmaceuticals. Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers. At Takeda, we do not ask for personal financial information during telephone, in-person or video interviews. And we are investigating ways to mitigate or stop this scheme. If you have concerns related to this issue, consider the following actions: 1) If in the U.S., place a freeze on your credit reports: 2) file a complaint with the U.S. Federal Trade Commission: and/or 3) file a report with your local police department.
Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task

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