Head of Quality (Port Elizabeth) at Aspen Pharma Group

Overview  

• Design and set Quality Policy and drive overall strategic direction for compliance to Quality and GMP standards and product specifications.
• Lead continuous alignment of pharmaceutical quality system in line with current and future global GMP and legal requirements.
• Develop systems to ensure that the SA Operations management team monitors compliance to pharmaceutical quality system and to lead GMP improvement initiatives.

Responsibilities

Compliance and continuous improvement

• Strategically action and mitigate GMP regulatory audit results and outcomes.
• Ensure policy and SOP compliance of facilities.
• Improve quality standards, integrating feedback from direct reports and from external regulators. 

QS Management

• Oversee the condition and relevance of the overall quality system.
• Guide in the formulation and maintenance of QS-related policies and procedures.
• Oversee the systems associated with deviation management, CAPAs, document control, quality risk management, root cause analysis, change control, the handling of product failures, and the recording and trending of related data.

QA management

• Oversee the management of quality procedures, standards and specifications and core QA activities for value streams.
• Ensure QA programs and activities are strategically aligned.
• Provide guidance and oversight in product release, retention sample management and in-process quality management.

QC management  

• Provide oversight for QC processes, including lab testing, customer service and deviation investigations, ensuring legal and regulatory compliance.

Vendor and audit management

• Ensure that supplier base is compliant with legislation, corporate policies and GMP standards and is capable of supplying cost-effective, high-quality services.
• Take responsibility for internal corporate and supplier audit programs.

Organisational support and function management

• Participate in the development and lead the implementation of the strategic vision and direction for business-critical functions across SA, as well as all related plans, policies and procedures.
• Perform financial and human resources functions to ensure optimal management of function and reporting units and their leaders.
• Manage collaboration and coordination between reporting units.
• Maintain and support positive customer engagements and problem resolution.

Requirements

Skills Required

Background/experience

• Minimum of Bachelor’s Degree in Pharmacy
• 8 – 10 years’ relevant managerial experience in a quality assurance environment.
• 5 years’ experience dealing with local and / or international regulators and audits.
• Project Management qualification / course will be an advantage. 

Specific job skills

• Subject matter expert on GMP, QS, Policies and Procedures
• Computer Literacy (Microsoft Office)
• Proven people and departmental management

Competencies

• Translating Strategy
• Interpreting and Internalising Information
• Managing Performance
• Customer Awareness
• Making Decisions