2 Senior Pharmaceutical Quality Assurance Manager Remote Compliance jobs in whatjobs
Senior Pharmaceutical Quality Assurance Manager - Remote Compliance
Posted 22 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Manager to ensure regulatory compliance and uphold the highest quality standards across their operations. This position is fully remote, allowing you to manage quality systems and compliance from your home office. You will be responsible for developing, implementing, and maintaining robust quality management systems (QMS) in accordance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines.
Key responsibilities include overseeing the quality assurance and quality control functions, ensuring product integrity and patient safety. You will lead internal and external audits, manage deviations, change controls, and CAPA systems. This role involves developing and delivering quality training programs to staff and ensuring adherence to established SOPs. You will also be responsible for reviewing and approving batch records, validation protocols, and other critical quality documents. Staying current with evolving global pharmaceutical regulations and ensuring the company remains compliant will be a core function. Collaboration with R&D, manufacturing, and regulatory affairs departments to address quality issues and implement corrective actions is essential.
Candidates must possess a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is preferred. A minimum of 8-10 years of progressive experience in Quality Assurance/Quality Control within the pharmaceutical industry is required. Demonstrated experience in developing and implementing QMS, leading audits, and managing regulatory inspections is essential. Strong knowledge of GMP, GLP, GDP, and relevant international regulatory guidelines (e.g., FDA, EMA) is a must. Excellent analytical, problem-solving, and decision-making skills are expected. Outstanding communication, leadership, and interpersonal skills are necessary for managing teams remotely and interacting effectively with regulatory bodies and internal stakeholders. The ability to interpret complex regulatory requirements and translate them into actionable quality procedures is crucial.
This is an exceptional opportunity for a seasoned quality professional to drive compliance and ensure excellence in pharmaceutical manufacturing remotely, supporting the company's operations and market presence, including in **Machakos, Machakos, KE**.
Key responsibilities include overseeing the quality assurance and quality control functions, ensuring product integrity and patient safety. You will lead internal and external audits, manage deviations, change controls, and CAPA systems. This role involves developing and delivering quality training programs to staff and ensuring adherence to established SOPs. You will also be responsible for reviewing and approving batch records, validation protocols, and other critical quality documents. Staying current with evolving global pharmaceutical regulations and ensuring the company remains compliant will be a core function. Collaboration with R&D, manufacturing, and regulatory affairs departments to address quality issues and implement corrective actions is essential.
Candidates must possess a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is preferred. A minimum of 8-10 years of progressive experience in Quality Assurance/Quality Control within the pharmaceutical industry is required. Demonstrated experience in developing and implementing QMS, leading audits, and managing regulatory inspections is essential. Strong knowledge of GMP, GLP, GDP, and relevant international regulatory guidelines (e.g., FDA, EMA) is a must. Excellent analytical, problem-solving, and decision-making skills are expected. Outstanding communication, leadership, and interpersonal skills are necessary for managing teams remotely and interacting effectively with regulatory bodies and internal stakeholders. The ability to interpret complex regulatory requirements and translate them into actionable quality procedures is crucial.
This is an exceptional opportunity for a seasoned quality professional to drive compliance and ensure excellence in pharmaceutical manufacturing remotely, supporting the company's operations and market presence, including in **Machakos, Machakos, KE**.
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Senior Pharmaceutical Quality Assurance Manager - Remote Compliance
Posted 1 day ago
Job Viewed
Job Description
Our client, a leading name in the pharmaceutical industry, is seeking a highly accomplished Senior Pharmaceutical Quality Assurance Manager to lead their global compliance efforts. This is a 100% remote position, offering the flexibility to work from anywhere. You will be responsible for ensuring that all pharmaceutical products and processes meet stringent regulatory standards and company policies. Your expertise will be critical in maintaining the highest levels of quality and integrity throughout the product lifecycle. This role requires a deep understanding of pharmaceutical regulations, quality systems, and a proactive approach to compliance.
Responsibilities:
Qualifications:
This is a significant opportunity for a seasoned QA professional to drive quality excellence in a remote capacity for a leading pharmaceutical company. If you are passionate about ensuring patient safety and product integrity, we want to hear from you.
Responsibilities:
- Develop, implement, and maintain a robust global Quality Management System (QMS) for pharmaceutical operations.
- Oversee all quality assurance activities, including batch record review, deviation management, CAPA (Corrective and Preventive Actions), and change control.
- Conduct internal and external audits (e.g., vendor audits, site audits) to ensure compliance with cGMP, ICH, FDA, EMA, and other relevant regulatory guidelines.
- Lead regulatory inspections and ensure successful outcomes.
- Manage product quality complaints and investigations.
- Prepare and review regulatory submission documents related to quality aspects.
- Provide training and guidance to internal teams and external partners on quality assurance best practices and regulatory requirements.
- Monitor and analyze quality metrics, identifying trends and implementing improvement initiatives.
- Collaborate with R&D, manufacturing, and other departments to ensure quality is integrated into all stages of product development and commercialization.
- Stay updated on evolving regulatory landscapes and industry best practices to ensure continuous compliance.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. Advanced degree preferred.
- Minimum of 8 years of experience in pharmaceutical quality assurance and regulatory affairs.
- In-depth knowledge of global pharmaceutical regulations (cGMP, ICH guidelines, FDA, EMA, etc.).
- Proven experience in developing and implementing QMS.
- Strong understanding of pharmaceutical manufacturing processes and analytical testing.
- Excellent auditing skills and experience leading regulatory inspections.
- Exceptional analytical, problem-solving, and decision-making capabilities.
- Outstanding written and verbal communication skills, with the ability to effectively interact with regulatory agencies and stakeholders globally.
- Demonstrated leadership and team management skills, with experience in managing remote teams.
- Proficiency in quality management software and tools.
This is a significant opportunity for a seasoned QA professional to drive quality excellence in a remote capacity for a leading pharmaceutical company. If you are passionate about ensuring patient safety and product integrity, we want to hear from you.
This advertiser has chosen not to accept applicants from your region.
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