Job#: 1243363 Job Description: Apex Systems has an exciting opportunity for a QA Manager for one of our Pharmaceutical clients located near Lansdale, PA.
The ideal candidate will want to make a difference by helping to improve people's quality of life. As a fast-growing contract research organization, you will have the opportunity to develop your skills and advance your career. If you stand out for your attention to details and your teamwork, don't hesitate to send us your application!
The QA Manager
will support the continued development and implementation of a practical quality management system. Must possess a quality oriented mind and technical knowledge to complement interpersonal skills of flexibility and collaboration. Effectively communicate and maintain open and timely execution of QA tasks across multi-disciplinary teams. Primary Responsibilities:
- Manages QA staff and resources to ensure efficiency across functions and sites.
- Responsible for staff development and align with strategic plan needs.
- Integrate internal and external quality information to quickly adapt and modulate QA activities.
- Application of risk assessment approaches within QA operations.
- Lead the coordination and logistics of sponsors and/or regulatory authorities inspections.
- Ensure QA operations consistently meet internal and external timelines.
- Second level of quality issue escalation / conflict resolution.
- Maintain and monitor Key Performance Index related to QA pertinence and timelines.
- Approve the annual internal audit program and ensure they are adequate and reflective of the needs identify from risk.
- Identify and coordinate training within the group.
- Author responses to regulatory agency and/or sponsor's audit findings to ensure they are adequate, complete, compliant, and appropriate.
- Prepare annual staff development plans, and provide resources towards their completion.
- Integrate quality inputs from the other departmental managers
- Provide quarterly quality reports to senior management, on initiatives, risk assessment approaches and results.
Education: Bachelor degree or higher, in Chemistry, Biochemistry, Biology, or equivalent field with a minimum of ten years experience, or equivalent combination of education and experience, in the pharmaceutical industry.
- Strong knowledge and understanding of US, Canadian and EU GMP Regulations and guidelines.
- Detail oriented.
- Project management and coordination skills.
- Ability to meet tight deadlines.
- Tactful, reliable, persuasive, dependable, consistent, flexible.
- Good written and oral communication skills
- Skills in software applications including Microsoft Office, QMS, and inventory management systems.
IT QA experience will not be considered. For immediate consideration, email a copy of your resume to David Neto at
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at