Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Formulation and execution of a viable, results-oriented strategy for assigned area
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Establish, promote and sustain a vision, mission, strategic and policies for quality assurance; communicate them to team, along with internal and external clients in a spirit of shared partnership
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Oversee the coordination and hosting ofcross-functionalSponsor Audits and Regulatory Inspections, as well provide management support to QA staff for Sponsor Audits andRegulatory Inspections
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Implement yearly risk-based audit plan for the area of responsibility, and continuously evaluate risk and adjust auditplan accordingly, coordinate with peers and ensure execution of the annual audit plan
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Champion and support compliance with applicable regulations, laws, Parexel procedures and policies
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Promote a vision and action for compliance and standards across the company, fostering cooperation, globalization and positive communication
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Articulate issues and concerns to senior / executive management in a constructive, clear and actionable manner; using metrics and data
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Works closely with Sr. Management to manage current issues and anticipate upcoming auditing needs
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Effectively lead and manage crisis situations, providing direction and solutions
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Act as Escalation Point within the Organization, as well as with external clients / regulatory authorities for any major compliance concerns, providing direction and solutions. Manage the assigned internal QA team, systems and process; coordinating with peers
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Actively manages performance consistent with the strategy/plan
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Anticipate problems, recognizing obstacles and seeking opportunities
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Delegate effectively, focusing on results, allowing others to learn and grow in a supportive environment
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Actively implement and support the use of Audit Management application and related metrics
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Motivate others through personal leadership and credibility
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Support the recruitment, supervision, training and mentoring of the QA team
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Work both independently, but in coordination and in conjunction with peers
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Provision of management support to team, including prioritization of tasks, evaluation and monitoring of quality and timeliness of work performed
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Provide technical support and problem resolution for the team, as needed
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Think and analyze issues globally, not only regionally
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Ensure training and development of team
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Build, develop, and maintain good working relationships with internal and external customer groups
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Develop and implement a budget for assigned area; communicating needs and changes with appropriate groups
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Be a role model, sharing yourself, your knowledge and ideas with others
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Build character in the team and company through actions and intentions
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Maintain relevant knowledge of appropriate GxP requirements and developments as they impact Parexel
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Maintain and / or develop records / documents, as required to meet the needs of the team, along with those of internal and external clients
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May serve as a member of industry association boards, task forces and committees and / or as chairperson or officer of one or more professional associations. Contributes expertise to professional societies, academic, or other similar groups influential in his /her area of expertise
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Aligns with Senior Management to manage current issues and anticipate upcoming auditing needs. Develop and implement a budget for assigned areas; communicating needs and changes with appropriate groups
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Build, develop, and maintain good working relationships with internal and external customer groups Work well in team environment
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Perform other quality related tasks or duties as assigned by QA management
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Travel internationally on assignments as required. Travel time could be up to approx. 60%.
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Demonstrate competence in quality assurance and management, emphasizing continuous improvement
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Knowledge of models and trends in quality assurance, ‘quality’ and management
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Ability to represent a positive attitude, recognizing it as a choice which determines actions and influence
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Ability to discern where to place efforts / actions, so it adds the greatest value and maximum impact
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Demonstrated ability to successfully manage multiple teams and multiple projects
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Ability to develop relationships with a culturally diverse group of key stakeholders within Parexel, the client’s business, and regulatory authorities
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Excellent interpersonal, verbal and written communication skills, including experience in making presentations at conferences, meetings and training sessions
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Experience with Microsoft based applications and ability to learn internal computer systems
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Willingness to work in a matrix environment and to value the importance of teamwork
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Ability to work flexibly and adjust to changing priorities and unforeseen events
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Diplomatically address sensitive issues confidentially and professionally
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Excellent knowledge of, and working experience with, relevant national / international regulations
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Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations
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Work independently and consistently in a fast-paced environment
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Ability to train and coach team
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Proven experience in pharmaceutical quality assurance, including international quality assurance, substantial experience in the GxP area, with demonstrable track record of establishing effective audit functions and teams; and with proven experience in managing people and projects
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15+ years’ experience in quality assurance or relevant area, including 5 years of applicable GxP auditing.
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7+ years managing a team
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Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
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Strong command of written and spoken English language, local language proficiency as required