Site Head Of Quality Management - Interim Management

SUMMARY OF POSITION:

Lead and be responsible for overseeing all QA/QC efforts & GMP activities within site.

Responsible for all aspects of GMP Quality Assurance, including developing operating philosophies, establishment and maintenance of a Quality Culture and establishing quality systems in alignment with Group Global Standards and international GMP regulations.

ESSENTIAL FUNCTIONS:

• Lead the GMP compliance efforts for API production process related to site
• Monitor and audit manufacturing for GMP compliance and serve as a key resource to production regarding quality and compliance issues.
• Develop, manage, and maintain appropriate procedures to ensure regulatory compliance. Establish and maintain key quality indicator elements, organize quality goals and objectives. Identify, assess and incorporate best demonstrated industry practices to assure GMP and regulatory compliance with all relevant Health Authorities (HA) and applicable external regulatory requirements and applicable guidance documents.
• Assure that Quality Systems are managed and continuously reviewed and improved for regulatory compliance and operating efficiencies.
• Manage and support all HA and other regulatory agency activities including inspections, inquiries, notifications, all and other agency associated activities.
• Apply modern principles of quality systems and strategic planning to products and processes to achieve sustainable quality and compliance performance.
• Establish and/or improve monitoring measures for key elements related to quality goal attainment. Analyze and report product and process quality trends, and quality system integrity against internal and external guidelines, standards and regulations.
• Supervise Quality Assurance Operations, Quality System & Quality Control departments
• Develop and conduct training for QA Associates and production personnel, as necessary. Ensures that QA department personnel are trained to perform their jobs effectively and ensure an efficient operation that is well integrated.
• Coordinate QA functions for the assigned area of responsibility and act as key compliance liaison with Supply Chain, Manufacturing, Packaging, Warehouse and other functional departments.
• Recognize need for investigation due to deviation from written procedures, conduct investigation into non-conformance, incidents/deviations and recommend disposition of the affected product/component.
• Prepare trend reports related to in-process monitoring, deviation reports, investigation reports. Follow up with functional department for timely completion of corrective and preventive actions recommended.
• Define/Perform annual and random audits of production, warehouse, maintenance, analytical laboratory, etc.
• Define & Implement continuous improvement plans in Quality departments
• Ensure timely in-process/final testing of API and others products.
• Notify any problems with in-process testing results to production immediately and investigate the incident, as appropriate.
• Maintain a thorough knowledge of appropriate standard operating procedures and applicable regulatory requirements and guidance documents.
• Perform personnel evaluation as needed.
• Develop QA/QC budgets.
• Perform other related duties as assigned from time to time based on company needs.

MINIMUM REQUIREMENTS:

• Bachelor’s Degree in chemistry, engineering or pharmacy with 10 years’ experience in an API/pharmaceutical Quality Assurance/Quality Control environment. Five (5) years of progressive leadership or supervisory experience in a Quality function of the pharmaceutical industry required.

Industry Knowledge:

• Knowledge and experience of applicable regulatory standards and requirements for the API manufacturing required – ICH Q7a…
• Knowledge of analysis of API utilizing UPLC/HPLC, GC, spectroscopic and wet chemistry techniques & microbiology.

Preferred Skills:

• Advance level of written and verbal communication skills with the ability to read, technical procedures or governmental regulations.
• Excellent verbal and written communication skills. Ability to write reports and required documentations.

o Experience in computer applications such as SAP, Minitab, Microsoft Word, Excel, Access and Power Point.

o Ability to communicate information with courtesy and tact

o Highly self-motivated

o Strong organizational skills

o Flexibility

o Strong Presentation skills

o Initiative and mature judgement

o Accuracy and attention to detail and completeness of tasks

• Reasoning Ability:
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.

Supervisory Controls:

• Effectively manage competing priorities, adaptable to change, demonstrated ability to accept additional responsibilities and manage tasks through teamwork.
• Demonstrated abilities to provide direction to employees, establishes the overall objectives and resources available, broadly defines missions and functions to the employees.
• Assures that finished work and methods used are technically accurate and in compliance with established guidelines and procedures.

• Summary of Core Competencies:
• WW/EU/US FDA regulatory compliance, GMP Quality Assurance, QA, good manufacturing practices, EU/US FDA cGMPs, auditing, inspection hosting, packaging, Quality Operations, Quality Control, plant floor, OPEX/Continuous Improvements QA team leadership, batch record review, batch release, product disposition

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

· Reports to Group Director, Quality Technical Operations/Chief Pharmaceutical Officer with dotted line responsibility over Site Director

· Frequent communication and working relationships with Sector manufacturing facilities and others sites.

· Contact with regulatory authorities during inspections