Quality Assurance Manager- Plough Center

Market Range: 12

Salary commensurate with education and experience

JOB SUMMARY/ESSENTIAL JOB FUNCTIONS:

Under the direction of the Director, this position is responsible for all xGMP compliant facility operations, ensuring compliance of Plough Center site manufacturing processes according to cGMP and xGMP regulations, implementing, maintaining, and monitoring all quality processes and overseeing all quality related matters.

DUTIES AND RESPONSIBILITIES:

1. Identifies and implements business process improvements to drive business performance and quality innovation.

2. Provides hands-on technical expertise on Quality Assurance standards and processes to team members.

3. Builds, monitors, and sustains a robust and effective quality system that delivers reliable, high-quality products.

4. Supports the quality team for all clients and US-FDA site audit, periodic correspondences and audit reports.

5. Collaborates with Director of Operations for continuing quality improvements and innovations, development of project budgets and monitors expenditures.

6. Collaborates with local Operations, Quality Management and Development to assure all products and processes are in accordance with company standards and quality to prevent quality and/or regulatory issues.

7. Provides hands-on technical leadership to ensure all necessary quality checks are completed timely and according to SOPs and protocols.

8. Identifies deviations from SOPs in manufacturing operations.

9. Manages and coordinates internal departments, customer, and regulatory audits and oversees tracking of CAPA’s for monitoring timely completion.

10. Reviews and approves site Standard Operating Procedures to ensure compliance with cGMP requirements.

11. Initiates and executes process and procedural changes to improve QA process performance, robustness, and efficiency.

12. Provides leadership in addressing all quality related needs and requirements with client projects, calls and meetings.

13. Performs other duties as assigned.

MINIMUM REQUIREMENTS:

EDUCATION: Bachelor’s Degree in Chemistry, Pharmaceutical Chemistry or Process Engineering. (TRANSCRIPT REQUIRED)

EXPERIENCE: Five (5) years of relevant work experience in quality assurance or quality department in a highly regulated GMP manufacturing environment. Must be familiar with GMP's and Quality System Regulations (QS Regulations) and practical judgment in the interpretation and application of regulations and standards specific to Quality Assurance for Biologics and or IVDs.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Strong scientific analytical and writing skills, proficient in MS Word, MS PowerPoint and MS Excel software.

• Experience with Software and Instrument System Process, Cleaning, Facilities/Utilities/Equipment and Analytical Method Validation.

• Experience with Design Control, Development of new assays and reagents or instrumentation.

• Experience with technical investigation of deviations and performing product impact assessments and product complaints.

• In-depth understanding of Manufacturing/Pharmaceutical Business.

• Strong team leadership skills.

• Strong staff coaching and development skills.

• Good ability to communicate.

• Strong understanding and appreciation for regulatory requirements and quality and compliance standards under which site is operating.

• Ability to serve as an active member of the Quality Management Team.

WORK SCHDULE: This position may be occasionally required to work evening, weekends, and have overnight travel.