Director, Quality Assurance

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