Senior Quality Manager
Anonymous
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Job summary
Anonymous, a prominent pharmaceutical organization, seeks a Lead Pharmaceutical Quality Assurance Manager in Cape Town to oversee quality operations, ensuring GMP-compliant manufacturing and distribution. You will lead a dedicated QA team, implement robust QMS, and uphold regulatory standards to ensure patient safety and product integrity.
The role emphasizes strategic leadership, regulatory expertise, and collaboration with cross‑functional teams to maintain high quality across all processes.
Qualifications
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or related field.
- 8+ years in pharmaceutical QA or QC with at least 3 years in leadership.
- Extensive GMP, ICH knowledge and regulatory requirements.
- Experience developing and implementing QMS.
- Proven leadership and team development experience.
- Experience with regulatory inspections and audits.
Responsibilities
- Develop and manage a comprehensive QA strategy aligned with GMP/ICH.
- Lead QA team, provide coaching, training and performance reviews.
- Oversee batch record review, deviations, CAPA and change control.
- Ensure compliance with national and international regulations.
- Conduct risk assessments and mitigation for product quality.
- Manage regulatory audits and customer inspections.
- Collaborate with R&D, Production, and Supply Chain to drive improvements.
- Review and approve validation protocols and reports.
- Monitor quality metrics and report to senior management.
- Stay updated on regulatory changes and best practices.
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Our client, a prominent pharmaceutical organization, is actively seeking an accomplished Lead Pharmaceutical Quality Assurance Manager to oversee quality operations in Cape Town, Western Cape . This pivotal role involves ensuring the highest standards of quality and compliance across all pharmaceutical manufacturing and distribution processes. The ideal candidate will possess a deep understanding of regulatory requirements and a proven ability to implement robust quality management systems. You will lead a dedicated team, fostering a culture of continuous improvement and adherence to Good Manufacturing Practices (GMP). This is a hands‑on leadership position based in our modern facility, offering a significant opportunity to shape the future of pharmaceutical quality in the region. We are looking for a strategic thinker with exceptional leadership skills and a commitment to excellence. The role is critical to maintaining our reputation for producing safe and effective pharmaceutical products. Join us in a vibrant city and contribute to a vital industry that impacts lives daily.
Our client, a prominent pharmaceutical organization, is actively seeking an accomplished Lead Pharmaceutical Quality Assurance Manager to oversee quality operations in Cape Town, Western Cape . This pivotal role involves ensuring the highest standards of quality and compliance across all pharmaceutical manufacturing and distribution processes. The ideal candidate will possess a deep understanding of regulatory requirements and a proven ability to implement robust quality management systems. You will lead a dedicated team, fostering a culture of continuous improvement and adherence to Good Manufacturing Practices (GMP). This is a hands‑on leadership position based in our modern facility, offering a significant opportunity to shape the future of pharmaceutical quality in the region. We are looking for a strategic thinker with exceptional leadership skills and a commitment to excellence. The role is critical to maintaining our reputation for producing safe and effective pharmaceutical products. Join us in a vibrant city and contribute to a vital industry that impacts lives daily.
- Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with regulatory standards (e.g., GMP, ICH).
- Lead and manage the Quality Assurance team, providing guidance, training, and performance management.
- Oversee all quality-related activities, including batch record review, deviation investigations, CAPA management, change control, and internal audits.
- Ensure compliance with national and international pharmaceutical regulations and guidelines.
- Conduct risk assessments and implement mitigation strategies to ensure product quality and patient safety.
- Manage external audits from regulatory authorities and customers, ensuring successful outcomes.
- Collaborate with Production, R&D, and Supply Chain departments to resolve quality issues and drive process improvements.
- Review and approve validation protocols and reports for manufacturing processes and equipment.
- Monitor key quality metrics and report on the overall quality performance of the organization.
- Stay updated on evolving regulatory requirements and industry best practices.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- A minimum of 8 years of experience in pharmaceutical Quality Assurance or Quality Control, with at least 3 years in a management or leadership role.
- Extensive knowledge of GMP, ICH guidelines, and other relevant regulatory requirements.
- Demonstrated experience in developing and implementing QMS.
- Proven ability to lead and develop a team.
- Strong analytical, problem‑solving, and decision‑making skills.
- Excellent communication, interpersonal, and negotiation skills.
- Experience with regulatory inspections and audits is essential.
- Proficiency in quality management software and tools.
- Ability to manage multiple priorities and work effectively under pressure.
Our client provides a highly competitive remuneration package, including an excellent base salary and performance‑based bonuses. Comprehensive medical, dental, and vision insurance are provided, along with a generous retirement savings plan. Opportunities for continuous professional development, including advanced training and conference attendance, are encouraged. You will be part of a forward‑thinking company that values its employees and fosters a culture of innovation and collaboration. Relocation assistance may be available for the right candidate. Contribute to a globally recognized pharmaceutical leader from the beautiful setting of Cape Town .
Our client, a prominent player in the manufacturing industry situated in the scenic city of Cape Town, Western Cape , is actively seeking a distinguished Lead Quality Assurance Manager . This executive position is crucial for maintaining and elevating the exceptional quality standards that define our client's products. The successful candidate will be responsible for spearheading all quality assurance initiatives, ensuring that every product leaving the facility meets rigorous international benchmarks. This role requires a strategic thinker with an unwavering commitment to excellence and a proven ability to implement robust quality management systems. Join a forward‑thinking company in the vibrant heart of Cape Town , where your leadership will directly impact product integrity and customer satisfaction.
Our client, a prominent player in the manufacturing industry situated in the scenic city of Cape Town, Western Cape , is actively seeking a distinguished Lead Quality Assurance Manager . This executive position is crucial for maintaining and elevating the exceptional quality standards that define our client's products. The successful candidate will be responsible for spearheading all quality assurance initiatives, ensuring that every product leaving the facility meets rigorous international benchmarks. This role requires a strategic thinker with an unwavering commitment to excellence and a proven ability to implement robust quality management systems. Join a forward‑thinking company in the vibrant heart of Cape Town , where your leadership will directly impact product integrity and customer satisfaction.
- Develop, implement, and manage a comprehensive quality assurance strategy aligned with organizational goals and industry best practices for the manufacturing sector.
- Lead and supervise the QA team, providing guidance, training, and performance evaluations to ensure high standards of work.
- Establish and maintain detailed quality control procedures, protocols, and documentation throughout the production process in Cape Town .
- Conduct regular audits of production facilities, processes, and products to identify areas of non‑compliance and implement corrective actions.
- Collaborate with cross‑functional teams, including R&D, production, and operations, to address quality issues and implement improvements.
- Manage supplier quality assurance programs, ensuring that all incoming materials and components meet specified requirements.
- Analyze quality data, identify trends, and generate reports for senior management on key quality metrics and performance indicators.
- Stay abreast of new quality management techniques, regulatory changes, and industry trends relevant to the Western Cape manufacturing landscape.
- Champion a culture of quality consciousness throughout the entire organization.
- A Bachelor's degree in Engineering, Chemistry, or a related scientific discipline. An advanced degree is highly desirable.
- A minimum of 10 years of experience in quality assurance or quality control roles, with at least 5 years in a leadership or management position within manufacturing .
- In-depth knowledge of quality management systems such as ISO 9001, GMP, and relevant industry‑specific standards.
- Demonstrated experience in statistical process control (SPC), root cause analysis, and failure mode and effects analysis (FMEA).
- Strong leadership, team management, and motivational skills.
- Excellent analytical, problem‑solving, and decision‑making capabilities.
- Exceptional communication and presentation skills, with the ability to influence stakeholders at all levels.
- Familiarity with regulatory requirements in the South African market and specifically for the Western Cape .
- Experience with lean manufacturing or Six Sigma methodologies is a plus.
Our client is pleased to offer a highly competitive salary package, including a generous base salary and potential for performance‑based incentives. The benefits package includes comprehensive medical aid coverage, a substantial pension fund contribution, and life assurance. Opportunities for professional growth through workshops, certifications, and conference attendance are readily available. Employees enjoy a generous annual leave entitlement and a supportive work‑life balance, reflecting our client's commitment to employee well‑being in Cape Town . This role offers the chance to make a significant impact on the quality standards of a renowned manufacturing entity in the Western Cape .
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