1+ months

Quality Director

Kelly Services
Rockville, MD 20851
Quality Manager/Quality Director

Direct Hire

Pharmaceutical experience preferred

Working with the Chief Medical Officer & VP for Quality & Regulatory Affairs, this leader will be responsible for helping design and implementing companys Quality Management System. This role will be responsible for ensuring that all quality requirements of the Company are met in a timely fashion during a period of rapid growth. Thus, the successful candidate will possess an expert knowledge base and extensive experience in the current regulatory and quality space, as well as a demonstrated ability to be forward thinking, creative and innovative.


Design and implement companys Quality Management System

Perform and coordinate the QA/QC department and duties within.

Review SOPs, STPs and revise accordingly

Maintain all Quality Assurance and Quality Control master files

Prepare and carry out validation activities as required.

Perform internal and vendor audits.

Documenting and reviewing quality requirements and agreements of raw materials with suppliers

Investigating and providing suggestions for quality and health and safety

Ensuring that manufacturing processes comply with standards

Recording, analyzing, distributing and archiving statistical information

Manage quality personnel and assets, to ensure all quality activities are achieved according to agreed schedules, budgets and organizational objectives.

Direct Quality Operations in driving compliance activities related to FDA regulations, and quality systems standards.

Hiring Standards

Bachelors degree; Degree in Chemistry, Biology or related life science is preferred. An advanced degree in Life Sciences, such as a Ph.D. is desirable.

10 + years of experience working in a GMP environment.

5+ years of experience in a Quality role in a pharmaceutical manufacturing environment.

Strong knowledge of quality systems and culture, GMP regulations and legal product registration processes for API and Pharmaceutical products

Preferred Experience

Experienced in 21 CFR Part 211 Quality Management Systems (5 years)

Experienced in ISO 13485 Quality Management Systems (5 years)

Experienced in SOPs, Reports and Document Control (5-10 years)

Experienced in Complaint Handling, CAPA, NCMR (5-10 years)

If you or anyone you know may be qualified and interested in this opportunity, please select CONFIRM INTEREST in this email and I will reach out to discuss details.

Christy Lewis Howington

Engineering Recruiter

Kelly Engineering Resources | Kelly Services

(678)319-4489 x. 233

**Why Kelly** **** **?**

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, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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.


Posted: 2020-07-27 Expires: 2020-09-26

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Quality Director

Kelly Services
Rockville, MD 20851

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