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25 days old

Direct Hire Quality Director

Kelly Services
Paramus, NJ 07652
**Kelly Services is seeking a Director of Quality for a Direct Hire position in Paramus, NJ.**


Our client is currently seeking a Director, Corporate Quality. The ideal candidate is enthusiastic, self-motivated and a self-starter. Under direct and minimal direction, the individual will be able to monitor, update, and manage the Quality Management Systems for the Paramus facility, and all outside relationships with business partners. Maintain the Quality Assurance and Quality Control for processes and procedures in accordance with the guidelines and regulations set forth by FDA and other regulatory agencies and authorities. Provide quality input, oversight, and assistance for the efficient functioning of the analytical and manufacturing operations of a GMP analytical laboratory, warehouse, and GMP Pilot Plant for production and control of clinical trial materials. Ensure compliance with GMP documentation and training.


The organization management works on a virtual model, with site management of a physical location setup as an FDA-registered GMP analytical laboratory and development facility in Paramus, NJ. The candidate is expected to have hands-on experience in all aspects of a pharmaceutical development and manufacturing organization to include analytical, research and development, formulation, GLP, and cGMP manufacturing of clinical trial materials. If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, our client is a rapidly expanding opportunity and would love to meet you!


Essential Functions


+ Knowledge of Quality Control and Quality Assurance process and procedures in the pharmaceutical industry.

+ Knowledge of current FDA, DEA, ICH, State of NJ, and OSHA guidelines and regulations.

+ Assist with Monitoring, Updating, Managing, and Maintenance of the Quality Management System to include but not limited to Document Control, Record Control, Filing Management, Investigations, Deviations, Change Controls, OOS/OOT, Personnel Training, CAPAs, Internal and External Audits, Vendor Management in order to comply with GMP and regulatory requirements for Phase I GMP.

+ Establish, Implement, Manage and Maintain procedures and documents to include but not limited to SOPs, STPs, Specifications, Investigations, Certificates of Analysis, Batch Records, Validation Protocols, Analytical Methods and Validation, Stability, Samples, and other documents as necessary.

+ Write, Review, Approve and Release authority on documentation in the quality management system.

+ Prepare, issue, and release procedures and documents applicable to the different areas of Quality Control, Quality Assurance, Analytical, Manufacturing, Inventory Control, Cleaning and Safety.

+ Oversee compliance with the established procedures.

+ Identify QMS gaps with problem-solving anticipation for resolution.

+ Contributes to all aspects of the day-to-day laboratory operations and creating and implementing laboratory operations systems and procedures, to assure the QC laboratory complies with all regulatory requirements to include stability, warehouse, validation, and other aspects of pharmaceutical analytical laboratory and manufacturing as deemed necessary.

+ Maintain rigor and high quality of execution and documentation complying with all regulations.

+ Conduct work in accordance with guidelines and requirements established by FDA Good Manufacturing Practices, Code of Federal Regulations, and other regulatory agencies.

+ Communicate clearly and concisely, both verbally and in the form of written reports, including drafting and review of protocols, SOPs, batch records, and regulatory documentation to support clinical development.

+ Identify and troubleshoot technical problems with equipment and analytical procedure.

+ Draft and execute analytical procedure qualification/validation protocols and write reports.

+ Design and conduct studies to optimize and improve the robustness of analytical procedures.

+ Assist in project management to establish and maintain timelines.


Qualifications:


+ Experience leading a Quality Unit of an FDA Registered Pharmaceutical Business

+ BS in the analytical, chemical, pharmaceutical or life sciences is minimum requirement

+ 3-10 years related experience and/or training; or equivalent combination of education and experience.

+ Must have demonstrated experience working in cGMP environment.

+ Must understand the difference between development and GMP quality requirements.

+ Must have demonstrated experience with Good Documentation Practices.

+ Excellent oral and written communication, computer, scientific and organizational skills.

+ Ability to work independently and as part of a team, self- motivated, adaptable and with positive attitude.

+ Ability to learn new techniques performs multiple tasks simultaneously, keep accurate records, follow instructions and comply with company policies.


Compensation


Our client will offer a competitive salary, generous bonus program and liberal PTO policy. The company also offers a comprehensive benefits package and pays a large portion of health insurance premiums. Company equity in the form of stock options will also be offered.



**APPLY NOW!**


**For immediate consideration, please send your resume in a WORD document to gaut985@kellyservices.com**


\#TJP2021_SPEC


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


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**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/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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-10-01 Expires: 2021-11-01

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Direct Hire Quality Director

Kelly Services
Paramus, NJ 07652

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