Quality Assurance (Snr) Specialist *** Program oversite for the QMS in a varied role including Auditing and Vendor Management! *** Lexington, MA

Reference: TMV080622B

Expiry Date: 28-09-2022

Categories Biotech, Manufacturing / Production, R & D

Salary: On Application

Job Type: Full Time

Location:
Middlesex County
United States

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Job Description

My client is a biotechnology company focused on delivering transformational therapies for patients with serious, genetically defined diseases. But they are different! They have a chemistry platform that enables them to develop potential medicines to reduce, restore or modulate proteins responsible for genetic diseases.

In the last few years, they have assembled an extremely talented and experienced team, led cutting-edge advancements in potentially disease-modifying treatments and initiated clinical trials in their lead programs. It’s an exciting time of progress, yet there is still much more to accomplish.

“This is a time of opportunity, to be part of a dynamic environment, to play a significant role at a growing organization, to be a part of a new era of life-changing medicines. You are invited to join a company with the potential to change the landscape of rare diseases.”

As part of their regional and global expansion plans, they are seeking Quality Assurance Specialists and Leaders to join their growing Quality team.

Sr. Quality Assurance Specialist - Provide program oversite for the QMS in a varied role including Auditing and Vendor management!

This a fairly new type of role that has a number of unique components. You will collaborate with colleagues from Supply Chain (SC), Quality Control (QC) and other teams in support of preclinical, clinical, and commercial product development in a cross functional role that also evaluates complaint trends and supports/drives improvements.

You will support/ provide leadership with the QMS, but also maintain the Internal audit schedule and provide metrics for the timelines and outcomes, working with internal teams to set up audits and ensure that timelines are met including communication (audit agendas, close out meetings, audit reports, internal team responses, and QA’s review of responses/CAPAs).

You will also participate in program oversite for on-time completion of the QMS (such as deviation, OOS, OOT, change control and CAPAs) and participate in investigations, root cause analysis, corrective or preventive actions having product quality impact. There will also be the opportunity to deploy supplier assessments to evaluate suppliers and participate in vendor audits.

There is flexibility to work from home (2 days) and be on-site (3 days) at the manufacturing site based in Lexington, MA.

The team is led by an experienced and engaging Head of Quality Assurance, who will look to help you develop your experience and prepare you for a more senior role – Growth and development within this QA department is the norm, its expected and encouraged!

On offer here is a competitive base salary, with a yearly bonus, company stock options, a very competitive overall benefits package.

Qualifications:

  • Bachelor’s degree in Biology, Chemistry, or a similar scientific field.
  • Minimum of 5 years of work experience in a Quality Assurance organization.
  • Must have experience working in a GMP environment in the pharmaceutical or biotechnology industry.
  • Experience with electronic systems including Veeva, Smartsheet, and SharePoint is preferred
  • Effective written and verbal communication skills.
  • Superior attention to detail, strong organizational skills and the ability to multi-task and work effectively in a highly-collaborative, cross-functional, fast- paced environment.

 

To Apply!

To apply for this role, please contact me Theo Moore on US 908-348-6714, alternatively, please send a full CV to me in confidence on Theo@AdvTalent.com and I will reply by return.

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