Job Description

POSITION SUMMARY:   Manage the development, establishment, and  maintenance of Quality systems, policies, processes, procedures and controls ensuring that performance and quality of cGMP documentation and records conforms to established standards.  This position will manage the Change Control, CAPA, Documentation Control, Quality Management Review processes.   The Quality Systems Manager will be responsible for continuous improvement of the Quality Systems in response to business needs, customer audits and regulatory inspections and overall oversight of the systems.   RESPONSIBILITIES: ESSENTIAL DUTIES

• Manages programs and activities within the quality assurance functions of an organization.
• Administers policies and programs ensuring that organizational products and processes meet established quality standards.
• Participates in the development, implementation and administration of an organizational quality management system and monitors progress against strategic quality related goals.
• Manages the work of a team of analysts that collect data identifying potential quality failures, evaluate quality of raw materials or components, in progress goods, processes or operations, and implement and measure the impact of corrective actions.
• Solicits internal and external feedback with the goal of continuously improving processes or products.
• Manage the Quality Systems group to ensure that systems and processes are operation in a state of control and in compliance with regulatory requirement and internal SOPs.
• Support and drive the ongoing implementation of Quality Management Systems
• Manage the document control function, including issuance and archival of GMP documentation, issuance of production records.  
• Review and approve corrective and preventive (CAPA) actions and ensure documents are closed in a timely manner.  
• Manage the CAPA system, ensuring appropriate CAPA are identified and implemented as required.
• Manage the SOP system to ensure that procedures are current and reflect the intended process.
• Administer the Change Control program to ensure all changes are appropriately assessed, documented, implemented and closed on time.
• Develop and track key Quality metrics and KPIs to monitor the performance of the Quality System; perform trend analysis
• Assist the Head of QA with all customer, third-party and regulatory audits including preparation of responses to audit and inspectional observations.  
• Responsible for personnel actions including hiring, performance management, termination

  The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.   General:  It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.   EXPERTISE: KNOWLEDGE & SKILLS

• Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.
• Manages activities of a functional area which has at least 2 departments or major functions through managers and/or experienced employees. Responsible for cost, method, and employee results.
• Judgement is required in resolving complex problems based on experience.
• Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.

EXPERTISE: QUALIFICATIONS -EDUCATION/EXPERIENCE/TRAINING/ETC  REQUIRED:

• Bachelor' s degree required.
• 08-10 years related experience required.
• Regular and predictable attendance
• Occasional business travel required