Director, Quality Assurance

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were 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-functionalSponsor Audits and Regulatory Inspections as well provide management support to QA staff for Sponsor Audits andRegulatory 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 clients 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