Quality Manager, Operations Quality Management
- Contract Type
PAREXEL currently has a great opportunity for a Quality Manager to join our Qualty Management team.
The role can based in Germany, Spain or Italy (office-based or decentralised)
Quality Manager serves as a quality consultant to designated operational group(s). The main activities will include: identification of process improvement opportunities, process authoring, and review and leadership, support for and leadership of process re-engineering, providing GxP and process expertise to designated operational group(s), support for identification, management and prevention of quality issues, providing audit and inspection support, and assisting with the collection and reporting of quality metrics as assigned. Provide leadership and direction to (Sr) Quality Specialists. Mentor and train (Sr) Quality Specialists. Supervise cross functional and complex Quality Management projects including oversight of team members as assigned. Represent function to senior leadership in other departments as assigned.
Process Development and Improvement
Work with Operations and QM to identify continuous improvement opportunities (based upon metrics quality and other objective information) and champion their implementation, as assigned.
Work with the Process Optimization and Management (POM) and operational groups; ensure timely review and maintenance of Controlled documents (e.g. SOPs, Work Instructions, Forms and Templates) in accordance with the defined timelines.
Represent Ops QM / SMQM for SBU and Corporate process improvement initiatives as required.
Maintain an excellent familiarity with PAREXEL project-related systems and related processes.
Remain informed about developments in relevant regulations and guidelines.
Where assigned work with Operational groups to provide partner review of client-defined processes, provide process support and consultancy to partnerships as assigned (Process Lead role)
General Quality Support
Work independently and provide expert advice to groups within the organization.
Provide quality consultancy to Operations personnel.
Complete or oversee the completion of assigned quality interventions/targeted/independent quality assessments. Verify compliance with GxP guidelines, local regulations, protocol, PAREXEL procedures and/or sponsor requirements.
Provide audit and inspection support as assigned. This may include: providing assistance/advice for audit/inspection preparation; representing Quality Management in audits and inspections as required; reviewing assigned audit/inspection
Develop designated operational group(s) specific interventions/targeted/independent quality assessments as assigned
Represent Quality Management in audits and inspections as required
Provide support for the management of quality issues. Facilitate Root Cause Analysis and advise on corrections, corrective and preventive actions related to designated quality issues
Support Operations staff in the use of automated quality systems; summarize automated quality system reports and provide metrics as appropriate.
Excellent interpersonal, verbal and written communication skills
Client and quality-focused approach to work
Strong project management and leadership skills
Ability to think and work globally and be culturally aware
Strong ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning
Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills
Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization
Ability to lead a cross functional team to ensure delivery on time and to required standard for Quality and Company initiatives
Ability to handle several highly complex projects/tasks simultaneously, potentially spanning different SBUs
IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions
English proficiency (written and oral English)
Ability to travel as needed
Knowledge and Experience:
Knowledge of GxP and compliance required
Previous quality management or process development experience preferred
Relevant pharmaceutical industry, CRO, Clinical or Medical experience
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, preferred