Kelly Engineering is currently recruiting for a (Direct Hire) (Manager, Quality Management System) job located in Rockville, MD. This position supports and enables the development of our next generation medicine manufacturing platforms. Our manufacturing platform is comprised of modules that can chemically synthesize active pharmaceutical ingredients, purify crude products, and formulate into finished drug products. These modules are miniaturized and mobile and can be deployed anywhere in the world to strengthen pharmaceutical supply chain and enable local production of medicines. Reporting to the VP for Quality & Regulatory Affairs, this position will have growth opportunity and responsibilities such as:
- Room for growth in this role for a director level Quality professional
- Unique combination of experiences in the most cutting edge end-to-end continuous cGMP pharmaceutical manufacturing and medical device development and manufacturing.
- Lead quality management system (QMS) development, implementation, and execution to US and international regulations and standards, including compliance to cGMP, ISO13485:2016, US 21 CFR requirements.
- Maintain a compliant and effective Document Control and Change Control process, with a cGMP manufacturing facility in scope.
- Manage the Internal and External QMS Audit programs; ensuring audit compliance and adequate follow-up to audit nonconformances.
- Develop and ensure the effectiveness of the deviation and CAPA program, with support from QA Scientists and QA Engineers.
- Support Management Reviews, serving as Quality System Management Representative (QSMR) with responsibility for generating required performance metrics and reporting the effectiveness of the QMS, to top management and identify any need for improvements to maintain compliance with regulations.
- Manage test methods and inspection procedures and the implementation of process control systems to support the development, qualification, and on-going pharmaceutical and/or medical device manufacturing activity, with a heavy emphasis on computerized systems.
- Manage a risk-based supplier qualification program, including qualification of suppliers, supplier corrective actions, supplier audits and review of Quality Agreements.
- Support risk management programs and partner with chemistry, engineering and manufacturing process development to drive design control processes.
- Partner with QA Scientists and QA Engineers, to support the development of validation strategies in partnership with Manufacturing Engineering to support production transfer of design projects.
- Partner with cGMP manufacturing team, review and/or approve documents including: Manufacturing batch records in support of product release; SOPs, Validation Protocols and Reports.
- Partner with QC personnel, support the maintenance and reporting of routine product bioburden and endotoxin monitoring for all applicable products
- Support Operations Team in the maintenance of a robust Environmental Monitoring program for the company's controlled-environment areas.
- Proactively investigate and analyze customer complaints, and oversee problem reporting to regulatory agencies.
- Coach and develop team members and supervise/train quality associates.
- Bachelor's degree in basic or applied science; an advanced degree is preferred
- Minimum 5 years of working experience in pharmaceuticals, medical device or other regulated industries and 3 years working experience focusing on QMS
- Experienced in using all electronic QMS tools.
- Working experience with ISO 13485:2016, ISO 14971, 21 CFR Part 210, 21 CFR 211
- Familiarity with ICH guidelines
- Working experience with electronic QMS, and qualification of computerized systems
- Ability to work with cross-functional teams and build strong working relationships
- Strong analytical, critical thinking and communication skills and team orientation
- Start-up or small company experience
- Experience in new product/process development and method/production transfer
- Experienced in establishing cGMP operations
Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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