Associate Director, Quality Assurance Systems
Our client is a specialty pharmaceutical company. They have asked us to assist them in their search for an Associate Director, Quality Assurance Systems.
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Oversees Quality functions, acts as named Quality person for the company.
- Interacts with regulatory agencies in regard to GXP matters.
- Manages and works to improve company’s current quality management systems and documents, and to establish Strategic Quality Objectives in support of development programs and company goals.
- Develops and maintains internal and external audit programs to satisfy contractual and regulatory requirements for GXP.
- Identifies, selects, and implements scalable software to support Quality systems.
- Coordinates the Quality review of documents for regulatory submissions.
- Oversees pre-approval inspection readiness.
- Develops and reviews qualification and validation plans and reports.
- Optimizes Quality Systems processes, including CAPA, Change Control, Document Control, Risk Management, identification of Critical Quality Events, etc.
- Establishes adequate GMP, GCP and GLP training programs for the Company to support aggressive growth plan.
- Manages and develop Quality Systems staff, as needed.
- Promotes Quality culture across functions.
- Requires life science qualifications with a minimum of 5 years of experience in quality assurance in the pharmaceutical industry.
- Must be a hands-on leader capable of performing lot release, data review, laboratory and facility audits.
- Experience managing contract manufacturing organizations highly preferred.
- GMP experience is required.
- Prior experience launching a product preferred.
- Must have knowledge of current GXP qualification and validation expectations.
- Experience with European quality guidance and Qualified Persons (QP) requirements preferred.
- Requires practical knowledge of implementation of I CH Q10 Quality Systems, especially Risk Analysis/Management, CAPA, Annual Product Reviews and Management Review and Supplier Quality Management.
- Must be an excellent team player and communicator.
- Must have the ability to demonstrate flexibility in the face of shifting priorities or unexpected occurrences in development.
- Requires good organizational and project management skills and attention to detail.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.