New facility build (King of Prussia area) in Q2 2021; in this role you would lead Quality across the plant (eventually a team of about 30 people at this site)
- Organization boasts 40+ year history, privately held, very profitable, cutting-edge technologies that continue to impress and acquire customers across the biggest industries; pharmaceutical, life sciences, energy, food/bev, petrochemical, power, pulp/paper, semiconductor, etc.
- Operations in 40+ countries; dynamic, growing organization is complex; with 25+ holding companies globally and 5 R&D centers.
Quality Manager (Greenfield Operations)
King of Prussia, PA
Our executive search firm is looking for a Quality executive to help lead ground-breaking operational efforts for a new facility (literally – greenfield operations!). This organization boasts 40+ year history, privately held (cash-heavy), and cutting-edge technologies that continue to impress and acquire customers across the biggest industries; pharmaceutical, life sciences, energy, food/bev, petrochemical, power, pulp/paper, semiconductor, etc. They manufacture / operate in more than 40 countries; yet do not have pharmaceutical clean-rooms in the USA; hence the birth of this project). This dynamic, growing organization is complex; with 25+ holding companies globally and 5 R&D centers.
Main area of focus:
We are looking for the key leader who will oversee quality control and assurance for a new API manufacturing facility; ensuring top notch compliance with all regulations and supporting facility audits.
You will be involved in all aspects of Quality; specifically pharmaceutical product laboratory techniques. Seeking knowledge of the following: ISO 9001:2015 standards, ISO 19011:2018 standards (principles of auditing, managing an audit program, conducting management system audits, guiding others through the audit process). FDA Audit experience strongly desired. This is both an exciting short-term role to be an integral part of the build out, and will ensure a long term, stable position with success!
Additional desired skill areas:
- You’ll be the representative for all quality matters including maintenance, renewals and audits. Communicates all deviations and non-conformances to plant management and senior leadership as needed. Works closely with global quality team. Key point of contact for external regulatory agencies.
- Develops and monitors capital expenses budgets for the department.
- Establish and oversee internal audit process to ensure lab is always audit-ready. Communicates with the authorities and customers and coordinate the planning of the GMP Inspections.
- Coordinate GMP Inspections that are performed by the authorities and customers; prepare responses to the Inspections Reports, submits them for internal approval and submits the approved responses to the authorities.
- Work closely with Life Sciences R&D team on product development and technology transfer.
- Analyze and approve general and operating procedures, work instructions and other quality-related documents developed in conformity with ISO 9001:2015, ICH Q7, FDA Guide – Title 21 parts 210 and 211, cGMP part II.
- Approve intermediate and API contract manufacturers.
- Releases or rejects all APIs, Excipients, and all pharmaceutical products. Releases or rejects intermediates for use outside the control of the manufacturing company. Establishes a system to release or reject raw materials, intermediates, packaging, and labeling materials.
- Makes sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates, where appropriate.
- Bachelor's Degree in Engineering (Chemical or Chemistry preferred), advanced degree desired
- Min 10 years’ experience in Chemical, Pharmaceutical, or similar manufacturing/leadership experience required;
- Min 3 years in a Supervisor/Managerial role
- GMP knowledge/experience
- Ability to lead quality control
- Demonstrated ability to set priorities, be flexible and manage multiple projects simultaneously.
- Proven ability to work in a fast-paced, detailed, and deadline-oriented environment by balancing multiple priorities and resources simultaneously.
- Excellent communication, interpersonal skills and interacts well with external customers, visitors, employees and management in other departments
- Computer literate with advanced writing skills.
- Can initiate tasks and work in an independent manner.