Director of Quality Assurance (QA)
Our client is one of the industry leading CMOs in reliability, technical excellence, and quality — Right and On Time.
With three facilities in the USA and Europe, they provide fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical, and commercial production.
They are experiencing growth in customer base and revenue, expanding personnel and manufacturing capacity as well as distinguishing themselves in the market with unique technology offerings for clients.
The Director of Quality Assurance (QA) is accountable for leading and managing the day-to-day activities of the QA Operations department. The position will drive the QA organization to meet the site’s business objectives as the site increases its focus on commercial manufacturing and advancing development products through commercialization. The Director will be responsible for QA lot disposition and support of manufacturing, facilities, QC, raw materials and vendor qualification.
- Develops, establishes and maintains quality assurance programs and systems, policies, processes, procedures and controls ensuring that performance and quality of products conform to established cGMP standards and regulatory requirements.
- Develops, implements and maintains quality systems (e.g., disposition) required for commercial operations from cGMP and operational efficiency perspectives.
- Manages QA support for the review and approval of documentation such as batch records, process and equipment validation protocols and reports, product specifications and change controls.
- Evaluates proposed process changes and improvements. Ensures proposed process changes are consistent with applicable regulatory guidelines and assures changes that affect a regulatory submission or require communication to regulatory authorities are appropriately conveyed.
- Provides expertise and guidance in interpreting existing and emerging governmental regulations, agency guidelines and internal policies to assure compliance.
- Leads and supports investigations associated with major deviations in operations.
- Represents company in dealing with clients and lead negotiation of quality agreements
- Partners with Manufacturing and QC to enhance the GMP compliance profile of the site by ensuring the timely closure of investigations and implementation of appropriate corrective actions.
- Ensures that all trends are evaluated, that root causes are identified and corrective actions are implemented.
- Authors, reviews and / or approves internal quality documents (SOPs, deviations, CAPAs, change controls, etc.) and external regulatory agency documents.
- BS in Physical Sciences, Life Sciences or Engineering; advanced degree is preferred
- 15+ years of relevant experience in a biotechnology and GMP environment
- Experience with QA and GMP compliance in clinical and commercial drug substance manufacturing
- Ability to understand and apply GMP regulations as they relate to manufacturing, raw materials, testing and facility operations
- Demonstrated ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated
- 10+ years in managing staff
- Strong interpersonal, written and oral communication skills
- Strong problem solving skills
- Strong management, staff development and mentoring skills
Our client values its employees, and this is reflected in the compensation and benefits packages we offer.
These packages include:
- Competitive base pay
- An annual bonus program based on company and individual performance
- Comprehensive benefits, including generous paid time off
- A dynamic and challenging work environment
- Opportunities for career development and advancement
Benefit Programs for U.S. Employees
We also offer a wide range of programs to help employees stay healthy, be financially secure, take a break from work, enhance career development, and have fun at work. A comprehensive benefits package is offered to regular full-time and part-time employees (working 24 or more hours per week) and, in some cases, their dependents.