Research QA Project Lead - Associate Director (Springfield)

  • Springfield, MA


: $146,240.00 - $146,240.00 /year *

Employment Type

: Full-Time


: Scientific Research

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Every day, employees working in Takedas Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients. Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference. What makes a successful member of our team? Check out the traits were looking for and see if you have the right mix. Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. Here, you will feel welcomed, respected, and valued as a vital contributor our global team. 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. Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. Drives strategic Quality activities to ensure that non-clinical GLP study activities conducted in-house and outsourced are in compliance with GLP or applicable regulations Fosters relationships with R&D staff to encourage discussion and evaluation of best practices for continuous improvement of quality and compliance across programs Provides professional expertise, guidance and strong leadership in Good Laboratory Practices (GLP) and other applicable regulatory requirements (e.g. CAP, CLIA, BA Guidance) to proactively identify compliance issues/risks in all Nonclinical, analytical and Bioanalytical studies within the organization and its external partners (as applicable) Provides regulatory / compliance expectations related to GLP and regulated laboratory activities to our stakeholders as subject matter experts (SMEs) and advise on quality related issues Provides oversight and leads QA professionals responsible for Research Quality Assurance supporting regulated laboratories and GLP activities (as applicable) Lead and assess (directly or via management of contract auditors) external service providers conducting GLP study activities and external analytical regulated laboratory activities Lead internal, external and supplier quality audits to assess quality management systems, adherence to applicable regulations/procedures and appropriateness for use by quality standards Assist in the development of key performance indicators (KPIs) and quality metrics for quality to drive process improvements ACCOUNTABILITIES: Provides professional expertise, guidance and leadership in Good Laboratory Practices (GLP) and other applicable regulatory requirements (e.g. BA Guidance Document, ISO, OECD, CLIA) to proactively identify compliance issues/risks in all Nonclinical, Analytical and Bioanalytical studies within the organization and external suppliers (as applicable) Liaise with various internal groups and external groups including Contract Research Organizations (CROs), regulatory bodies, expert consultants and vendors, to maintain a high level of quality and consistency across the programs / projects in Research Accountable for identifying quality risks to non-clinical programs and developing mitigation strategies in partnership with the business Leads and implements appropriate audit programs to ensure that regulated non-clinical studies are in compliance with applicable regulations. Participate in regulatory inspections and ensures GLP inspection readiness (as applicable) Keeps up with the up-to-date applicable regulations and ensures that Research Quality staff is trained on the interpretation and application of applicable regulations. Independently perform qualification audits of suppliers Maintain GLP training program to ensure that personnel are appropriately trained to carry out GLP responsibilities Review and audit compliance documents, SOPs, and protocols in support of GLP regulated activities DIMENSIONS AND ASPECTS : Technical/Functional (Line) Expertise Comprehensive knowledge and understanding of domestic and international GLP regulations, Bioanalytical Guidance Document and good documentation practices. Thorough understanding of analytical assays, method development and laboratory operations Independent broad range QA Auditing skills and ability to articulate quality related risk and potential impact Technical writing skills Firm understanding of the drug development processes, nonclinical operations, regulatory compliance and GLP auditing Leadership Develop and maintain audit plans on an annual and ongoing basis Apply strategic thinking to the oversight and management and development of supplier audit planning & scheduling Update and maintain required Research Quality Assurance audit program (internal and external) related documentation Ensure alignment with Global Quality approach Ensure compliance with change management processes and communicate to stakeholders regulatory compliance changes and updates (as applicable) Decision-making and Autonomy Independently perform issue analyse assessments and determine impact Apply problem solving skill to achieve a compliant resolution Able to formulate an strategic approach for difficult complex issues Interaction Talent to communicate and persuade others to entertain a more compliant approach Skills to defuse volatile/emotional situations to facilitate a cooperative conservation and build relationships Innovation Strong judgment, project management and decision-making skills; demonstrated ability to take a big-picture approach to decision-making while taking account of the broad interests of Takeda Supports a culture of innovation, while recognizing the need for an appropriate culture of compliance Complexity Mature, problem solving attitude, exhibits judgment and realistic understanding of the issues; able to use reason even dealing with emotional topics and have the interpersonal skills to deliver tough messages Requires a high degree of problem-solving ability; understanding objectives and processes across R&D and corporate functions and when escalation is necessary EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Bachelors degree required (or equivalent combination of education and experience). Advanced degree preferred Minimum of 9 years of increasing responsibility and experience in the pharmaceutical industry Minimum 6 years GLP QA experience. In depth knowledge of international regulatory requirements and industry guidelines on GLP Ability to influence and work effectively with various business partners. Advanced knowledge of the drug development process. Demonstrates excellent written and verbal communication skills in English. Work independently with minimal supervision Demonstrates excellent business skills such as critical thinking, strategic planning, and time management Notice to Employment / Recruitment Agents: Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takedas Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration. Equal Employment Opportunity Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. EEO is the Law - EEO is the Law Supplement - Pay Transparency Policy - Reasonable Accommodations Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-###-#### and let us know the nature of your request and your contact information. 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Associated topics: bacteria, cytometry, dietician, drug discovery, histotechnologist, medicine, nutritionist, pharmaceutical, pharmacometrics, trauma

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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