Quality Management Opportunities at Parexel
By being hired into one of our Quality Management jobs at Parexel International, you’ll be a key member of the Parexel International team. Professionals in Quality careers come from a variety of backgrounds, bringing an assortment of knowledge and skills to every area of our business. A job in Quality at Parexel International may be waiting for you!
Associate Director, Quality AssuranceJob ID 60641BR Singapore, Singapore, Singapore
- The role is accountable for the formulation and execution of a viable, results-oriented strategy for assigned area.
- Responsible for assessing and verifying compliance with GxP standards, consistent with applicable laws, regulations, Parexel policies and procedures, client contracts and procedures, and other standards as may be applicable to particular, situations.
- Provide leadership and direction to team, possessing vision, technical competence, outstanding communication skills, pragmatism, a bias for action and cooperative approach to problem solving with internal and external clients. Communicate compliance issues to management.
- The role is also responsible for financial discipline and forecasting of resources within the group.
- Establish, promote and sustain a vision, mission, strategic and policies for execution of a quality assurance; communicate them to team, along with internal and external viable, results- clients in a spirit of shared partnership-oriented strategy
- Ensure on site QA liaison during regulatory inspections of Parexel for assigned area facilities
- Manage the assigned internal QA team, systems and process; coordinating with peers
- Develop an annual audit plan, coordinating with peers and ensure its execution
- 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 the QA database and related metrics
- Motivate others through personal leadership and credibility
- Support the recruitment, supervision, training and mentoring of the QA team
- 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
- Work both independently, but in coordination and in conjunction with peers
- Provide 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
- Effectively lead and manage crisis situations, provide direction and solutions
- 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
- Works closely with Senior Management to manage current issues and anticipate upcoming auditing needs.
- Develop and implement a budget for assigned area; communicating needs and changes with appropriate groups
- Build, develop, and maintain good working relationships with internal and external customer groups
- Perform other quality related task or projects as assigned by QA management
- Travel as needed
QualificationsKnowledge and Experience:
- Proven experience in pharmaceutical quality assurance, including international quality assurance, including substantial experience in the GCP area, with demonstrable track record of establishing effective audit functions and teams; with relevant experience managing people and projects.
- 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
- Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
- Master’s degree in a science, technology or industry related discipline is preferred
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