Ref No.

SYS-508

Location

US ~ Boothwyn, PA

Site Head of Quality Assurance

 Company Overview

Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success.  With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.

People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.

The Role

Due to growth and expansion, we have an exciting opportunity for a Site Head of Quality Assurance to join Quotient Sciences, Philadelphia.  As the Site Head of Quality Assurance, you will be responsible for managing the QA team at Quotient Sciences – Philadelphia and ensuring company’s adherence to Good Manufacturing Practices (GMPs), Good Documentation Practices, global (e.g., FDA, EMA, PMDA) regulatory standards, and internal procedures and practices for all product development, manufacturing and testing activities. You will also be responsible for supporting efficient supply chain from receiving materials to shipping products.

  

Other tasks and responsibilities will include:

 

Manage all client projects to assure that Quality Assurance responsibilities of applicable regulations are fulfilled.

Provide full and timely QA support to manufacturing, analytical/QC, Facilities & Engineering and other departments

Manage general compliance of the site. Manage documents such as Quality agreements, Quality Manual and Site Master File and regulatory documents such NDA/ANDA and Annual Product Report (APR).

Host client and regulatory audits.

Plan, direct and conduct internal compliance audits regulated under GMP.

Track and trend quality metrics such as out-of-specification (OOS) results, deviations, change controls, complaints, and recalls or field alerts.

Report quality metrics regularly to the Company’s leadership team.

Lead investigations and resolve potential quality issues to prevent recurrence.

Able to make quick sound decisions related to quality issues.

Optimize and streamline systems to conform to GMP and company polices while meeting production and testing needs.

Plan, direct and conduct external compliance audits of analytical services vendors, excipient and component providers, and other vendors as applicable.

 

The Candidate

The successful candidate will have strong managerial and supervisory skills required to guide change in workplace culture and lead transition and integration activities taking place throughout our global organization. The candidate must be a hands-on, participative manager who will lead and develop an internal team. This position will be a member of the senior leadership team and will play a critical role in strategic decision making and directing operations of the organization:

1) B.A. or B.S. degree in a scientific field, e.g., chemistry, biology, or pharmacology; fifteen (15) or more years related pharmaceutical products experience; and ten (10) or more years’ experience in a management position in a GMP/pharmaceutical environment or equivalent.

2) Strong interpersonal skills with a special focus to customer satisfaction

 

Other essential skills and experience are:

Thorough knowledge of GMP principles, solid dosage manufacturing, International Conference on Harmonization (ICH) guidelines, OSHA and DEA regulations
Able to resolve conflicts internally and with clients
Thorough knowledge of Quality Risk Management and Data Integrity regulations.
Experience working in manufacturing and/or laboratory environment
Familiarity with the production process
Successfully completes regulatory and job training requirements

 

Company benefits:

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

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