Vacancies

Compliance Specialist

Job Title:Compliance Specialist
Reference:QA-22-13-1
Location US ~ Boothwyn, PA
Type: Full Time

Company Overview

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.

As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.

Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

 

The Role

  • Maintain Quality Management System to be compliant with current regulatory expectations.
  • Support site-wide quality initiatives.
  • Serve as QA SME for quality incident management, training, validation activities, supplier oversight, and internal audit.

Main tasks and responsibilities will include:

  • Provide compliance guidance to site staff.
  • Author, review and approve reports, SOPs and protocols as needed.
  • Work closely with manufacturing, facilities, IT, and QC/AD departments to meet Client and Quotient Sciences milestones.
  • Demonstrate regulatory and compliance proficiency in the area of Quality Assurance. 
  • Support validation efforts.  Review and approve IQ/OQ/PQ documentation.
  • Prepare/assist during GMP training.
  • Perform internal and supplier audits and manage audit schedules.
  • Reviews and approves suppliers SCARs.
  • Provide guidance to external departments and facilitate risk assessments and gap-analyses.  
  • Assist with quality metrics analysis and reporting to Site and Global Quality Management as needed.

Additional task/responsibilities

  • Provide support to client audits and regulatory inspection
  • Aid clinical and commercial quality assurance when necessary
  • Provide project leadership on site-wide quality initiatives

 

The Candidate

  • Bachelor’s degree in physical or life sciences field, e.g. Chemistry, Pharmaceutical Sciences, Engineering
  • At least ten (10) years of experience working within a GMP regulated environment
  • At least five (5) years of experience working in Quality Assurance
  • Experience working in a pharmaceutical analytical or manufacturing environment
  • Knowledge of QMS ComplianceWire system

 

Company benefits

In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.

 

Our Commitment to Diversity & Inclusion

Quotient Sciences are advocates for positive change and conscious inclusion.

We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.

As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.

If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at careers@quotientsciences.com.