Group Quality

2 weeks ago


Durban North, South Africa Aspen Pharma Group Full time

**ROLE PURPOSE**

Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers to create an interdependent global manufacturing Regulatory and Quality network committed to deliver compliant, reliable supply of medicines to customers and patients by:

- Driving continuous improvements and integration of quality and regulatory ways of working
- Providing technical expertise to Aspen stakeholders with regards quality and regulatory matters across the Group
- Development of regulatory policies and procedures in consultation with Aspen Affiliates, aligned with the GMP requirements and process within the different Aspen entities as ensuring appropriate systems, tools, procedures and training are available
- Oversight of the QMS for the Aspen Group.

**KEY PERFORMANCE AREAS**

**Support Business Integration of APHL, Affiliates / IP Owner - Regulatory and Quality**
- Lead, implement, sustain and monitor compliance with GMP and product safety requirements
- Ensure business processes and products continuously meet the regulatory requirements and GMP.
- Drive continuous improvements and integration of quality and regulatory ways of working with Aspen stakeholders and with external customers.
- Establish and implement quality and regulatory metrics to drive consistent compliance.
- Provide technical expertise to Aspen stakeholders.
- Lead or participate in continuous Improvement projects.
- Development of regulatory policies and procedures in conjunction with Aspen Affiliates aligned with the GMP requirements and processes within the different Aspen entities including ensuring appropriate systems, tools, procedures, and training are available.

**Regulatory Oversight**
- Monitor activities under the responsibility of the Group Regulatory Manager ensuring the execution
- Provide support and insight on all Regulatory and compliance matters for the Group to allow for sound decision making

**Integration into strategic projects**
- Provide regulatory and quality expertise on strategic projects to support business objectives.
- Ensure effective management of resource and participation in site strategic projects that impacts regulatory and quality areas

**Alignment with GOQC**
- Ensure alignment of Head of GOQC on QMS Policies and implementation.

**Leadership & Team Management**
- Coach and Manage a Team
- Set up objectives for each team members and review periodically.
- Manage the capacity of the team members and monitoring the workload and ensure the completion in a timely manner.
- Communication of the company strategy, objectives, etc.
- Guide staff on daily activities to be performed and provide technical knowledge.
- Seek for development of the staff, succession planning.
- Recruitment of new staff.
- Set-up and manage the budget for the department.
- Manage escalations to the senior management.
- Write executive reports.

**EDUCATION QUALIFICATION AND EXPERIENCE**
- Bachelors or Post Graduate degree in Chemistry, Pharmacy or equivalent degree (Science degree).
- A minimum of 10 years pharmaceutical industry experience within GMP Quality Assurance and Regulatory.
- A minimum of 3-5 years in leadership role.
- Experience in managing regulatory or quality across multi sites/ geographies
- Pharmaceutical industry experience
- Knowledge in Pharmacovigilance is advantageous
- Ability to interpret business strategy and translate into operational excellence
- Ability to multitask projects of varying complexities.
- Manage budget of the department.

**SKILLS AND ATTRIBUTES**
- Ability to work in an international and dynamic environment
- Strategic planning
- Global thinking
- Leadership
- Problem-solving and good judgment
- Resource efficiency
- Risk management
- Change Management
- Cooperation
- Networking skills
- Negotiation skills
- Aspen knowledge
- Organisational awareness
- Written and verbal communication skills
- Project Management
- Organisational awareness
- Influence skills
- Ability to work within tight timelines
- Stakeholder management
- Ability to analyse data sets
- Ability to work cross functionally and with diverse teams

**KNOWLEDGE**
- Advanced knowledge of Quality Management Systems, cGMP & regulatory requirements.
- Auditing experience is advantageous
- Knowledge of basic financial principles
- Project Management
- Intermediate to Advance Microsoft Office proficiency (Excel, Word and Power Point)
- Document management and quality systems (e.g. TrackWise)

**ASPEN COMPETENCIES**

**Business**
- Create the Future
- Make Good Decisionsp
- Foster Consumer and Customer Commitment

**People**
- Develops Talent, Teamwork and Diversity
- Lead and Influence Others

**Self**
- Demonstrates a passion for Aspen
- Contribute Special Expertise
- Take Action with Integrity

Aspen is committed to the principles of equal employment opportunity. Preference will be given to applicants from designated groups through a fair recruitment and selection process in line with Aspen’s



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