Full Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. 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. Key Accountabilities: Formulation and execution of a viable, results-oriented strategy for assigned area 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 Oversee the coordination and hosting of cross-functional Sponsor Audits and Regulatory Inspections, as well provide management support to QA staff for Sponsor Audits and Regulatory Inspections Implement yearly risk-based audit plan for the area of responsibility, and continuously evaluate risk and adjust audit plan accordingly, coordinate with peers and ensure execution of the annual audit plan Champion and support compliance with applicable regulations, laws, Parexel procedures and policies Promote a vision and action for compliance and standards across the company, fostering cooperation, globalization and positive communication Articulate issues and concerns to senior / executive management in a constructive, clear and actionable manner; using metrics and data Works closely with Sr. Management to manage current issues and anticipate upcoming auditing needs Effectively lead and manage crisis situations, providing direction and solutions 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 Actively manages performance consistent with the strategy/plan Anticipate problems, recognizing obstacles and seeking opportunities Delegate effectively, focusing on results, allowing others to learn and grow in a supportive environment Actively implement and support the use of Audit Management application and related metrics Motivate others through personal leadership and credibility Support the recruitment, supervision, training and mentoring of the QA team Work both independently, but in coordination and in conjunction with peers Provision of management support to team, including prioritization of tasks, evaluation and monitoring of quality and timeliness of work performed Provide technical support and problem resolution for the team, as needed Think and analyze issues globally, not only regionally Ensure training and development of team Build, develop, and maintain good working relationships with internal and external customer groups Develop and implement a budget for assigned area; communicating needs and changes with appropriate groups Be a role model, sharing yourself, your knowledge and ideas with others Build character in the team and company through actions and intentions Maintain relevant knowledge of appropriate GxP requirements and developments as they impact Parexel Maintain and / or develop records / documents, as required to meet the needs of the team, along with those of internal and external clients 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 Work closely with QA Senior Management 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 Build and maintain relationships Build, develop, and maintain good working relationships with internal and external customer groups Work well in team environment Perform other quality related tasks or projects as assigned Perform other quality related tasks or duties as assigned by QA management Travel internationally on assignments as required. Travel time could be up to approx. 60%. Skills: Demonstrate competence in quality assurance and management, emphasizing continuous improvement Knowledge of models and trends in quality assurance, ‘quality’ and management Ability to represent a positive attitude, recognizing it as a choice which determines actions and influence Ability to discern where to place efforts / actions, so it adds the greatest value and maximum impact Demonstrated ability to successfully manage multiple teams and multiple projects Ability to develop relationships with a culturally diverse group of key stakeholders within Parexel, the client’s business, and regulatory authorities Excellent interpersonal, verbal and written communication skills, including experience in making presentations at conferences, meetings and training sessions Experience with Microsoft based applications and ability to learn internal computer systems Willingness to work in a matrix environment and to value the importance of teamwork Ability to work flexibly and adjust to changing priorities and unforeseen events Diplomatically address sensitive issues confidentially and professionally Excellent knowledge of, and working experience with, relevant national / international regulations Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations Work independently and consistently in a fast-paced environment Ability to train and coach team Knowledge and Experience: 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 Education: 15+ years’ experience in quality assurance or relevant area, including 5 years of applicable GxP auditing. 7+ years managing a team Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience Strong command of written and spoken English language, local language proficiency as required Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™