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PAREXEL

Director, Quality Assurance

PAREXEL
Singapore
15-17 Years

This job is no longer accepting applications

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  • Posted 2 months ago

Job Description

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

More Info

Job Type:
Permanent Job
Industry:
Other
Function:
Quality Assurance
Employment Type:
Full time

About Company

PAREXEL

Job ID: 144833027

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Last Updated: 05-05-2026 06:09:56 PM
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