Job Information
Parexel Director, Quality Assurance in Singapore, Singapore
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
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.