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- Tasks: Oversee QA activities for commercial drug products and ensure compliance with regulations.
- Company: Growing pharmaceutical company with a focus on quality and patient safety.
- Benefits: Competitive daily rate, flexible working arrangements, and valuable industry experience.
- Why this job: Make a real impact in the pharmaceutical industry while supporting a key role during maternity leave.
- Qualifications: Experience in pharmaceutical QA, CMO oversight, and strong communication skills.
- Other info: 12-month contract with opportunities for professional growth and networking.
The predicted salary is between 100000 - 140000 £ per year.
- QA CMO Manager, 12-month Contract (MAT Cover)
- Addlestone, Surrey – 1x a quarter on site
- £500 per day – Inside IR35
Cpl Life Sciences is partnering with a growing pharmaceutical company that is looking for a QA CMO Manager on a 12-month basis.
The purpose of the assignment is to maintain CMO oversight/management and associated activities during the maternity leave of the permanent CMO manager.
CMO QA Oversight:
- Oversees the cGMP activities and processes for commercial drug substances, intermediates, and in-process and finished drug products manufactured by CMOs, supported by the line management.
- Provides QA oversight for technology transfers of commercial products to and between CMOs.
- Provide QA support for regulatory agency inspections at CMOs as necessary.
- Participate in CMO Business Review Meetings.
- Facilitates the resolution of all deviations, non-conformances and other batch related quality issues with the CMO to ensure product compliance.
- Employs a Risk Management approach to evaluate Quality issues to ensure that drug substances, intermediates, and in-process and finished drug products manufactured by CMOs conform to all regulatory and business product specifications.
Interactions: Internal
- Product and Project management
- CMC RA
- Quality assurance
- Legal
- Supply chain
- Technology and Manufacturing External
- Contract Manufacturing Organizations
Prior Experience:
- Influencing: ability to communicate with stakeholders, clearly provide QA assessments, reasoning and align to consistently ensure compliance and patient safety
- Decision making
- Project management
- Previous experience in pharmaceutical Quality Assurance, CMO oversight or in-plant GMP pharmaceutical manufacturing
- Experience working with Biologics
For more information, please reach out to me at lucy.kirkaldy@cpl.com
QA CMO Manager employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA CMO Manager
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who have experience with CMO oversight. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of cGMP activities and quality assurance processes. We want you to be ready to impress with your expertise and show how you can tackle challenges in QA management.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation. It keeps you fresh in their minds and shows your enthusiasm for the role.
✨Tip Number 4
Apply through our website! We’ve got loads of resources to help you land that QA CMO Manager gig. Plus, it’s a great way to ensure your application gets the attention it deserves.
We think you need these skills to ace QA CMO Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the QA CMO Manager role. Highlight your experience in pharmaceutical Quality Assurance and any relevant CMO oversight. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this 12-month contract. Share specific examples of your past experiences that relate to the job description, especially around cGMP activities and regulatory inspections.
Showcase Your Communication Skills: Since influencing and clear communication are key for this role, make sure to demonstrate these skills in your application. Whether it's through your CV or cover letter, we want to see how you can effectively engage with stakeholders and ensure compliance.
Apply Through Our Website: Don't forget to apply through our website! It’s the best way for us to receive your application and keep track of all candidates. Plus, it shows you're keen on joining our team at StudySmarter!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your CMO Oversight
Make sure you brush up on your knowledge of CMO oversight and cGMP activities. Be ready to discuss specific examples from your past experience where you've successfully managed quality assurance processes or resolved deviations. This will show that you understand the role and can hit the ground running.
✨Prepare for Regulatory Questions
Since you'll be providing QA support for regulatory inspections, it's crucial to prepare for questions related to compliance and regulatory standards. Familiarise yourself with the latest regulations in the pharmaceutical industry and think of instances where you've navigated these challenges successfully.
✨Showcase Your Communication Skills
As a QA CMO Manager, you'll need to influence and communicate effectively with various stakeholders. Prepare to demonstrate your communication style and how you've aligned teams in the past. Consider using the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Demonstrate Risk Management Acumen
Employing a risk management approach is key in this role. Be prepared to discuss how you've evaluated quality issues in previous positions and the strategies you used to mitigate risks. Highlight any specific tools or methodologies you've employed to ensure product compliance.