Job Description
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The Head of Quality Assurance is responsible for leading all quality and compliance activities across our sites. They ensure systems are in place and complied with, so we operate in accordance with applicable regulatory requirements.
This key leadership role has recently become available as we position ourselves to continue expanding in the market.
The successful candidate will promote and maintain a quality culture, prioritizing patient welfare, compliance to regulatory expectations, and continuous improvement.
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Key Responsibilities
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* Contribute to the definition of the business strategy by understanding key regulatory trends and identifying opportunities to drive improvement in compliance and quality.
* Define Pharmaceutical Quality Systems (PQS) requirements and track, trend, and communicate performance.
* Ensure all quality activities meet or exceed relevant regulatory requirements and expectations.
* Represent us on regulatory forums relevant to manufacture, supply, or sponsorship of therapeutic goods.
* Manage routine regulatory inspections and maintain appropriate manufacturing licenses.
* Project manage quality projects.
* Effectively manage the department through sound leadership, guidance, and open communication.
* Meet all department KPIs.
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Our company values diversity and is committed to creating an inclusive workplace for all employees.
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Requirements
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The successful candidate must have:
* Tertiary qualifications in a science discipline or relevant industry experience.
* A minimum 5 years' experience in pharmaceutical manufacturing and GMP.
* Ability to work in a fast-moving manufacturing environment with contemporaneous release.
* Demonstrated focus on business planning and strategic implementation.
* Demonstrated knowledge of regulatory expectations for manufacture and supply of sterile medicines and controlled drugs in our key markets.
* Demonstrated ability to develop and coach a team to achieve set outcomes and desired behaviors.
* Demonstrated ability to effectively and independently solve problems while ensuring quality standards are not compromised.
* Proven leadership and people management skills.
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Benefits
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We offer a global reach, growth opportunities, and a chance to make a difference in patients' lives.
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Seniority Level
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Executive level.
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Employment Type
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Full-time employment.
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Job Function
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Quality Assurance specialist.
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Keywords: quality assurance, pharmaceutical manufacturing, GMP, leadership, teamwork, problem-solving.