Quality Manager - CL

Key Accountabilities:

General Quality Manager

• Identify process improvement opportunities and champion their implementation, as assigned.
• Work independently and provide expert advice to groups within the organization.
• Provide mentoring, leadership, direction and training to new and existing Quality Specialists.
• Participate in SOP and process development as assigned.
• Participate in development of quality-related processes and tools.
• Provide quality consultancy to Functional Leads, Line Manager, and / or Project Leader / Project leadership.
• Work with the relevant training functions including Parexel Learning & Development and Operations. Assist with the development or enhancement of training materials, as assigned.
• 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.
• Develop designated operational group(s) specific interventions / targeted / independent quality assessments as assigned.
• 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 responses. Request audits of investigational sites, local offices or processes as needed.
• Provide support for management of quality issues. Facilitate and advice on corrections and corrective actions related to designated quality issues. Develop preventive actions and ensure resolution by Operational or Line Management staff, or Quality Management. Facilitate local compliance to the corrective and preventive action (CAPA) program.
• Perform Process Lead role for enterprise accounts and / or growth accounts or provide process support, as assigned.
• Attend (or where required, lead) internal quality-focused meetings.
• Maintain a familiarity with Parexel systems and related processes, Parexel Standard Operating Procedures and relevant regulations and guidelines.
• Perform other process, quality or training related tasks for particular workgroups (e.g. Line Managers, Leads) or project teams as assigned.
• Remain informed about developments in relevant regulations and guidelines.
• Share information in an open, balanced and objective manner with other
• Quality Management and other Parexel professionals to maintain positive, results-oriented team environment.
• Deputize for manager as assigned.
• International travel required of approx. 10%

Head of Quality Control

• May execute QC checks of Medicinal Products and other quality critical Clinical Trial Supplies during receipt, production and distribution
• Oversee all Quality Control activities in local depot/warehouse
• Instruct and train QC staff and other depot staff as needed
• Perform QC release of Medicinal Product batches and batches of other quality critical Clinical Trial Supplies (CTS)
• Oversee premise and equipment (P&E) maintenance and cleaning
• Approve Product Specifications and Master Batch Records
• Review and approve Production Batch Records and Test Records
• Perform and support P&E qualification/validation activities as appropriate
• Undertake local P&E Quality tasks as defined in Parexel procedures to cover local QA tasks
• Oversee local Premise-specific and operational related change control procedures and quality issue (QI) reporting
• Receive advice from with local QPs (Qualified Person), RPs (Responsible Pharmacist) or APs (Authorized Persons)
• May act as Backup for the Responsible Pharmacist in LATAM-region as per local legislation (not allowed in other regions). Details on Delegation rules and requirements are documented in UP-CTSL-WW-005 Personnel Responsibilities.

Skills:

• Excellent interpersonal, verbal and written communication skills.
• Client-focused approach to work.
• Project management and leadership abilities.
• Ability to work independently, takes initiative, and has 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.
• IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions.
• Ability to travel as needed for the position.
• Ability to think and work globally and be culturally aware.
• Ability to handle several highly complex projects/tasks simultaneously, potentially spanning different SBUs.

Knowledge and Experience:

• English proficiency (written and oral English)
• Knowledge of GMPGDP regulations required
• Training experience, as appropriate, required
• Relevant experience in Quality Management preferred
• Relevant experience in the Clinical Research field (GCP), clinical or medical experience or other relevant experience in the areas Logistics Quality Management (LQM) support preferred
• Technical Leadership / Project Management / Technology / Business Operations experience, as appropriate, preferred

Additional Requirements for Head of Quality Control Role:

• Receive approval from local QPs (Qualified Person), RPs (Responsible Pharmacist) or APs (Authorized Persons) before entering into the HQC-role
• Receive approval from local GMP/GDP surveillance authorities before entering into the HQC-role
• Local language proficiency (written and oral)

Experience

• 5-8 years of relevant experience.

Education:

• 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