Do you have significant direct Quality Assurance (QA) experience in a biologics organisation?

Would you like to manage all quality aspects of projects and ensure they comply with cGMP requirements?

Are you located in Maryland, US, or are you willing to relocate?

Fraser Dove International is working exclusively with an established biotechnology organisation specialising in pioneering cell therapies and new medicines. Operating worldwide, they are dedicated to becoming the world’s leading pharma healthcare organisation.

Our client is seeking a proactive leader to provide Quality and Compliance oversight to all activities specific to Bioscience Research and Technology (R&T) related projects.

Discover more about our Senior Quality Assurance Project Manager opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.

Your objectives:

As the Senior Quality Assurance Project Manager, you will be measured against the following objectives:

1) Overseeing all activities specific to Bioscience Research and Technology (R&T) related projects.
2) Working cross-collaboratively and making independent quality-related decisions based on regulatory and compliance knowledge.
3) Providing guidance and reviewing documents supporting Bioscience R&T projects including technical transfer documents.

What you will do:

As the Senior Quality Assurance Project Manager, your duties and responsibilities will include:

  • Managing the status of cross-functional team members regarding the quality aspects of a project.
  • Planning and executing R&T projects to ensure compliance with cGMP requirements.
  • Providing oversight for compliance of validation master plan, design documentation, technical transfer requirements and reviewing final reports.
  • Addressing compliance replated concerns regarding specific projects.
  • Acting as the Quality Assurance (QA) representative on cross-functional teams.
  • Making independent quality-related decisions based on regulatory and compliance knowledge.
  • Auditing internal quality system elements of research and development projects to ensure technical transfer to manufacturing and support areas is completed on time and in compliance with cGMP regulations.
  • Collaborating with internal QA management and team members to ensure alignment with current site Standard Operating Procedures (SOPs).
  • Maintaining a sense of urgency to manage QA aspects of projects to ensure timelines are met.

What you will bring:

These are the skills and experience you will need to succeed as the Senior Quality Assurance Project Manager:

  • Team orientated with an exemplary ability to foster strong and long-lasting relationships.
  • Exceptional ability to work both independently and collaborate with others.
  • Ability to multi-task and shift priorities quickly while working under time constraints. Strong work ethic and determination to succeed.
  • Excellent written and oral communication to include accurate and legible documentation skills.
  • Substantial GMP related experience in biologics or related industry with significant QA experience.
  • Bachelor’s degree in life sciences required.

What you will get:

These are the perks and benefits that will complement your generous base salary:

  • 20% bonus.
  • Full relocation package.
  • 401k
Got what it takes?

To apply for the Senior Quality Assurance Project Manager, click the ‘Apply’ button below or contact the Executive Search Consultant – Kaitlin Francis – on +44 (0)203 355 7050.

Please Note:
  • This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
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Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.

If you’re exploring executive opportunities in the life sciences, get in touch with our executive search consultants, upload your CV or apply for our life science executive jobs.