US ~ Boothwyn, PA
Director of Quality Assurance - Commercial Products
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.
Due to growth and expansion, we have an exciting opportunity for a Director of Commercial Products Quality Assurance to join the Quality Assurance Department. As the Director of Commercial Products Quality Assurance, you will be responsible for managing Quality Assurance team at Quotient Sciences – Philadelphia and ensuring company adherence to Good Manufacturing Practices (GMPs), Good Documentation Practices, global (e.g., FDA, EMA, PMDA) regulatory standards and internal procedures and practices for all commercial products manufacturing and testing activities.
Other tasks and responsibilities will include:
- Manage projects and direct reports to assure that Quality Assurance responsibilities of applicable regulations are fulfilled.
- Provide full and timely QA support to manufacturing, QC, Facilities and other departments within Quotient Sciences
- Select, develop and evaluate personnel to ensure the efficient operation of the function is fulfilled.
- Manage/Review compliance 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 external compliance audits of analytical services vendors, excipient and component providers, and other vendors as applicable.
- 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 (equipment), complaints, and recalls or field alerts.
- Lead investigations and resolve potential quality issues to prevent recurrence.
- Able to make quick sound decisions related to quality issues.
- Report quality metrics periodically as required by management.
- Optimize and streamline systems to conform to GMP and company policies and production and testing needs.
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:
- B.A. or B.S. degree in a scientific field, e.g., chemistry, biology, or pharmacology; seven (7) or more years related commercial pharmaceutical products experience; and five (5) or more years’ experience in a management position in a GMP/pharmaceutical environment or equivalent.
- 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.
- Strong interpersonal skills with a special focus on customer satisfaction
Other essential skills and experience are:
- Understanding of GMP principles, solid dosage manufacturing, International Conference on Harmonization (ICH) guidelines, OSHA and DEA regulations
- Able to effectively handle conflict/resolution situations between different departments and inter-department
- 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.
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.