- 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
- 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
- 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
- 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
- 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
- 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:
- Bachelor s 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 Takeda s 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 - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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 484-595-8400 and let us know the nature of your request and your contact information.