What are the responsibilities and job description for the Quality Assurance Manger position at LHH?
LHH Recruitment Solution is assisting a pharmaceutical client in the New Jersey area. The Quality Assurance Manager will be responsible for ensuring compliance with all relevant regulations, guidelines, and standards in the pharmaceutical industry. This individual will play a vital role in maintaining the highest level of quality throughout our organization. The successful candidate will oversee quality assurance activities, manage a team of quality professionals, and collaborate with cross-functional teams to implement effective quality systems.
Responsibilities:
1. Develop and implement a comprehensive quality assurance strategy in accordance with industry best practices and regulatory requirements.
2. Establish and maintain quality assurance policies, procedures, and systems to ensure compliance with cGMP (current Good Manufacturing Practices) and other applicable regulations.
3. Provide leadership and guidance to the quality assurance team, including hiring, training, and performance management.
4. Conduct internal audits to assess compliance with quality standards, identify areas for improvement, and ensure timely resolution of non-conformances.
5. Collaborate with cross-functional teams, including manufacturing, research and development, regulatory affairs, and supply chain, to ensure quality standards are met at all product lifecycle stages.
6. Develop and maintain key quality performance metrics and regularly report on quality performance to senior management.
7. Stay abreast of industry trends, changes in regulations, and emerging quality issues, and proactively recommend and implement appropriate actions to address them.
8. Participate in regulatory inspections and audits, including preparation, coordination, and response to findings, ensuring compliance with regulatory requirements.
9. Drive continuous improvement initiatives to enhance quality systems, processes, and procedures.
10. Foster a culture of quality and compliance throughout the organization, promoting a proactive approach to quality assurance.
Qualifications:
1. Bachelor's degree in pharmacy, pharmaceutical sciences, chemistry, or a related field. Advanced degree is a plus.
2. Minimum of 7 years of experience in quality assurance, with at least 3 years of managerial experience in the pharmaceutical industry.
3. Strong knowledge of cGMP regulations and other relevant quality standards (e.g., ICH guidelines).
4. Proven experience leading and managing a team of quality professionals.
5. Demonstrated experience in implementing and maintaining quality systems.
6. Excellent understanding of quality control processes, validation, and documentation practices.
7. Strong analytical and problem-solving skills, with the ability to identify root causes and develop effective corrective and preventive actions.
8. Detail-oriented mindset with exceptional organizational and time management skills.
9. Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to both technical and non-technical stakeholders.
10. Self-motivated and able to work independently as well as in a team-oriented environment.
Salary: $100,000-$140,000
If you are a dedicated and experienced quality assurance professional seeking a challenging opportunity in the pharma sector, we encourage you to apply for this position.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records
Responsibilities:
1. Develop and implement a comprehensive quality assurance strategy in accordance with industry best practices and regulatory requirements.
2. Establish and maintain quality assurance policies, procedures, and systems to ensure compliance with cGMP (current Good Manufacturing Practices) and other applicable regulations.
3. Provide leadership and guidance to the quality assurance team, including hiring, training, and performance management.
4. Conduct internal audits to assess compliance with quality standards, identify areas for improvement, and ensure timely resolution of non-conformances.
5. Collaborate with cross-functional teams, including manufacturing, research and development, regulatory affairs, and supply chain, to ensure quality standards are met at all product lifecycle stages.
6. Develop and maintain key quality performance metrics and regularly report on quality performance to senior management.
7. Stay abreast of industry trends, changes in regulations, and emerging quality issues, and proactively recommend and implement appropriate actions to address them.
8. Participate in regulatory inspections and audits, including preparation, coordination, and response to findings, ensuring compliance with regulatory requirements.
9. Drive continuous improvement initiatives to enhance quality systems, processes, and procedures.
10. Foster a culture of quality and compliance throughout the organization, promoting a proactive approach to quality assurance.
Qualifications:
1. Bachelor's degree in pharmacy, pharmaceutical sciences, chemistry, or a related field. Advanced degree is a plus.
2. Minimum of 7 years of experience in quality assurance, with at least 3 years of managerial experience in the pharmaceutical industry.
3. Strong knowledge of cGMP regulations and other relevant quality standards (e.g., ICH guidelines).
4. Proven experience leading and managing a team of quality professionals.
5. Demonstrated experience in implementing and maintaining quality systems.
6. Excellent understanding of quality control processes, validation, and documentation practices.
7. Strong analytical and problem-solving skills, with the ability to identify root causes and develop effective corrective and preventive actions.
8. Detail-oriented mindset with exceptional organizational and time management skills.
9. Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to both technical and non-technical stakeholders.
10. Self-motivated and able to work independently as well as in a team-oriented environment.
Salary: $100,000-$140,000
If you are a dedicated and experienced quality assurance professional seeking a challenging opportunity in the pharma sector, we encourage you to apply for this position.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records
Salary : $100,000 - $140,000
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