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- Tasks: Lead and manage the QA team, ensuring compliance with quality standards.
- Company: Join a dynamic pharmaceutical company focused on quality and innovation.
- Benefits: Enjoy competitive salary, career growth opportunities, and a supportive work environment.
- Why this job: Make a real impact in drug quality while developing your leadership skills.
- Qualifications: B.S. in a Science-related field and 5+ years of QA management experience required.
- Other info: Onsite position located in Massachusetts, perfect for those passionate about quality assurance.
The predicted salary is between 43200 - 72000 £ per year.
Job Title: Quality Assurance Manager Location: Massachusetts (Onsite) Job Type: Full-time Job Description We are seeking an experienced Quality Assurance Manager to lead and manage our Quality Assurance (QA) team. The ideal candidate will ensure that all quality processes comply with regulatory standards and align with business objectives. This role involves overseeing the Quality Management System (QMS), maintaining compliance with current Good Manufacturing Practices (cGMP), and fostering continuous quality improvement. Duties and Responsibilities Supervise and mentor the Quality Assurance (QA) team, including responsibilities for recruitment, training, and performance coaching. Oversee and manage the Quality Management System (QMS), ensuring adherence to regulatory standards for drug quality, strength, identity, and purity throughout production and storage. Develop, implement, and maintain Standard Operating Procedures (SOPs) related to quality assurance activities. Design and implement programs to enhance quality standards and ensure compliance with business and regulatory requirements. Define and enforce inspection standards within the QA department. Conduct and manage internal audits to verify compliance with cGMP requirements. Develop and oversee a company-wide cGMP Training Program. Lead the Change Control Committee, ensuring proper documentation and approval for facility, equipment, product, and process modifications. Review and approve operational procedures related to manufacturing, production, testing, and maintenance, including associated documentation. Ensure proper quality controls are in place and successfully executed during manufacturing operations. Analyze and address any discrepancies found in production records. Serve as the QA department’s representative in various organizational meetings. Develop, manage, and monitor the department’s annual budget. Oversee the hiring process and manage personnel changes within the QA department. Direct and oversee the daily operations of the QA Department. Qualifications and Experience Education: B.S. in a Science-related field (Chemistry, Biology, Pharmacy) or equivalent. Experience: Minimum of 5+ years of managerial experience in a QA environment, preferably in the generics pharmaceutical industry. Expertise: Extensive knowledge of cGMP requirements and Quality Assurance functions. Skills: Strong written and verbal communication skills, problem-solving abilities, and attention to confidentiality. If you are a highly motivated QA professional with leadership experience and a strong background in cGMP compliance, we encourage you to apply. #QualityAssurance #FDA #generics #Quality #pharmaceutical #J-18808-Ljbffr
Quality Assurance Manager employer: Barrington James Limited
Contact Detail:
Barrington James Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Manager
✨Tip Number 1
Familiarise yourself with the latest cGMP regulations and Quality Management Systems. Being well-versed in these areas will not only boost your confidence but also demonstrate your commitment to quality assurance during interviews.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those working in QA roles. Attend industry conferences or local meetups to build connections that could lead to job referrals or insider information about our openings.
✨Tip Number 3
Prepare to discuss specific examples of how you've led teams and improved quality processes in your previous roles. Highlighting your leadership experience and problem-solving skills will set you apart from other candidates.
✨Tip Number 4
Research StudySmarter and our company culture. Understanding our values and mission will help you tailor your approach during interviews, showing that you're not just a fit for the role, but also for our team.
We think you need these skills to ace Quality Assurance Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Assurance, particularly in the pharmaceutical industry. Emphasise your managerial experience and any specific achievements related to cGMP compliance.
Craft a Compelling Cover Letter: Write a cover letter that showcases your leadership skills and your understanding of quality management systems. Mention specific examples of how you've improved quality processes in previous roles.
Highlight Relevant Qualifications: Clearly state your educational background, especially if you have a degree in a Science-related field. Include any certifications or training related to quality assurance and regulatory compliance.
Showcase Soft Skills: In your application, emphasise your strong communication skills and problem-solving abilities. These are crucial for a Quality Assurance Manager role, so provide examples of how you've effectively communicated within teams or resolved issues.
How to prepare for a job interview at Barrington James Limited
✨Showcase Your Leadership Skills
As a Quality Assurance Manager, you'll be expected to lead a team. Be prepared to discuss your previous leadership experiences, how you've mentored team members, and any successful projects you've overseen. Highlight specific examples that demonstrate your ability to inspire and manage a team effectively.
✨Demonstrate Knowledge of cGMP
Since the role requires extensive knowledge of current Good Manufacturing Practices, make sure you brush up on these regulations before the interview. Be ready to discuss how you've implemented cGMP in past roles and how you ensure compliance within a QA environment.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving abilities and decision-making skills. Think of situations where you've had to address discrepancies in production records or manage internal audits, and be ready to explain your thought process and actions taken.
✨Understand the Company’s Quality Objectives
Research the company’s quality objectives and any recent news related to their QA practices. This will not only show your interest in the position but also allow you to tailor your responses to align with their goals, demonstrating that you're a good fit for their team.
