Director, Quality Assurance

KeyAccountabilities

Formulationand 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 ofcross-functionalSponsor Audits and Regulatory Inspections, as wellprovide management support to QA staff for Sponsor AuditsandRegulatory Inspections
• Implement yearly risk-based audit plan for the area ofresponsibility, and continuously evaluate risk and adjust audit planaccordingly, coordinate with peers and ensure execution of the annualaudit plan
• Champion and support compliance with applicableregulations, laws, Parexel procedures and policies
• Promote a vision and action for compliance andstandards across the company, fostering cooperation, globalization andpositive communication
• Articulate issues and concerns to senior / executivemanagement in a constructive, clear and actionable manner; using metricsand data
• Works closely with Sr. Management to manage currentissues and anticipate upcoming auditing needs
• Effectively lead and manage crisis situations,providing direction and solutions
• Act as Escalation Point within the Organization, aswell as with external clients / regulatory authorities for any majorcompliance concerns, providing direction and solutions. Manage theassigned internal QA team, systems and process; coordinating with peers
• Actively manages performance consistent with thestrategy/plan
• Anticipate problems, recognizing obstacles and seekingopportunities
• Delegate effectively, focusing on results, allowingothers to learn and grow in a supportive environment
• Actively implement and support the use of AuditManagement application and related metrics
• Motivate others through personal leadership andcredibility
• Support the recruitment, supervision, training andmentoring of the QA team
• Work both independently, but in coordination and inconjunction with peers
• Provision of management support to team, includingprioritization of tasks, evaluation and monitoring of quality andtimeliness of work performed
• Provide technical support and problem resolution forthe team, as needed
• Think and analyze issues globally, not only regionally
• Ensure training and development of team
• Build, develop, and maintain good working relationshipswith 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 andideas with others
• Build character in the team and company through actionsand intentions
• Maintain relevant knowledge of appropriate GxPrequirements and developments as they impact Parexel
• Maintain and / or develop records / documents, asrequired to meet the needs of the team, along with those of internal andexternal clients
• May serve as a member of industry association boards,task forces and committees and / or as chairperson or officer of one ormore professional associations. Contributes expertise to professionalsocieties, academic, or other similar groups influential in his /her areaof expertise

Work closely with QA Senior Management

• Aligns with Senior Management to manage current issuesand anticipate upcoming auditing needs. Develop and implement a budget forassigned areas; communicating needs and changes with appropriate groups

Build and maintain relationships

• Build, develop, and maintain good working relationshipswith 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 asassigned by QA management
• Travel internationally on assignments as required.Travel time could be up to approx. 60%.

Skills

• Demonstrate competence in quality assurance andmanagement, emphasizing continuous improvement
• Knowledge of models and trends in quality assurance,‘quality’ and management
• Ability to represent a positive attitude, recognizingit as a choice which determines actions and influence
• Ability to discern where to place efforts / actions, soit adds the greatest value and maximum impact
• Demonstrated ability to successfully manage multipleteams and multiple projects
• Ability to develop relationships with a culturallydiverse group of key stakeholders within Parexel, the client’s business,and regulatory authorities
• Excellent interpersonal, verbal and writtencommunication skills, including experience in making presentations atconferences, meetings and training sessions
• Experience with Microsoft based applications andability to learn internal computer systems
• Willingness to work in a matrix environment and tovalue the importance of teamwork
• Ability to work flexibly and adjust to changingpriorities and unforeseen events
• Diplomatically address sensitive issues confidentiallyand professionally
• Excellent knowledge of, and working experience with,relevant national / international regulations
• Analyze complex situations / issues and effectivelycommunicate situations / issues, along with potential recommendations
• Work independently and consistently in a fast-pacedenvironment
• Ability to train and coach team

Knowledge and Experience

• Proven experience in pharmaceutical quality assurance,including international quality assurance, substantial experience in theGxP area, with demonstrable track record of establishing effective auditfunctions and teams; and with proven experience in managing people andprojects

Education

• 15+ years’ experience in quality assurance or relevantarea, including 5 years of applicable GxP auditing.
• 7+ years managing a team
• Educated to degree level (technology, biologicalscience, pharmacy or other health related discipline preferred) orequivalent qualification or clinical research experience
• Strong command of written and spoken English language,local language proficiency as required

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