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
