Director, Quality Assurance

Organization
Catalent Pharma Solutions
Job Location
Morrisville, NC
Job Description

Position Summary 
The Director of Quality is responsible for setting the strategic direction, properly staffing and maintaining the Quality Management Systems (QMS) to assure the site is complaint at all times. They are responsible for  establishing and maintaining the site metrics, management review, and building a Patient First culture at the site. The Director of Quality at the site is the most responsible person for batch disposition. The Director of Quality is responsible to provide project guidance and support and work with customers to resolve quality concerns as appropriate. and customer requested quality trending
About Catalent 
Catalents +1,500 strong, international quality team is focused on delivering nearly 7,000 products to patients in over 80 countries with the highest level of quality standards across multiple superior drug delivery and manufacturing technologies at more than 30 facilities.

•As the #1 industry partner we are accredited by over 35 regulatory agencies world-wide.
•We have an industry-leading Quality Management System involving over 1,500 quality management professionals at over 30 sites around the world.
•We work with nearly all of the top pharmaceutical and consumer health companies and are an extension of their supply chains and quality systems.
•Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands that are used by families every day. 



Requirements: 

The Role 

•Develop and implement Qualitylan, objectives and related procedures.
•Maintain and enhance an effective Quality Management System (QMS)
•Interface with all other departments to ensure compliance with cGLP/cGMP.
•Monitor site compliance to FDA, EU and all other applicable requirements.
•Establish a process to review and Implements site procedures in alignment with the Corporate policies.
•Direct a team of Quality professionals. Provide development and disciplinary actions as needed to assure the department remains engaged and motivated
•Approve or reject, starting materials, packaging materials, and intermediate, finished products, and to evaluate batch production records.
•Ensure that all necessary QC testing is performed on manufactured products.
•Approve specifications, sampling instructions, test methods and other Quality Control procedures; to approve and monitor any contract analysts.
•Review and Approve site Annual Product Reviews
•Ensure that all required validation activities are completed.
•Ensure the required initial and continuing training is carried out and adapted according to need.
•Responsible for ensuring the environmental monitoring and control of the manufacturing environment and plant hygiene.
•Require approval and monitoring of suppliers of materials.
•Ensure the proper designation and monitoring of storage conditions for materials and products.
•Serve as site's primary contact with both customers and regulatory agencies regarding quality/compliance issues.
•Analyze, resolve, or assist in solving compliance and customer issues.
•Ensure customer audits are managed for success and timely audit response letters.
•Prepare approve and Mmanage QA departmental budget.
•Recruit/hire QA management and staff.
•Manage staff who each supervise diverse groups of audit/document control staff.
•Ensure that GLP/GMP documentation is backed up by secondary media and archived appropriately.
•Ensure that Document Control activities are compliant with FDA, EU and other applicable requirements and that controlled documents are maintained in an orderly manner to allow rapid retrieval when required.
•Stay informed regarding industry trends, interpretation of regulations and application to the RTP site.
•All other duties as assigned. 
The Role 
Education and Experience:

•Bachelors degree in chemistry or closely related field; 10-12 years directly related experience 
Knowledge, Skills and Abilities:

•Ability to organize time for multiple tasks (major projects and daily functions)
•Delivers assigned tasks on time
•Schedules and executes work
•Function and problem solve independently without supervision
•Good communication and organizational skills
•Formal presentation skills to co-workers or customers
•Usually supplies and seeks information where exceptional tact and courtesy is needed
•Ability to bring projects to a timely completion using Catalent systems
•Good working knowledge of the subject area
•Knowledge of cGMP, GLP, ICH, and USP regulations or guidelines
•Supply and seek information where exceptional tact and courtesy is needed
•Has extensive knowledge of area of responsibility and considered an expert
•Good understanding of the pharmaceutical industry and regulations applicable for a contract testing laboratory
•Knowledge of a production/technical field such as pharmaceutical analysis at various stages of product development
•Lead a group of 20-30 employees effectively 
Physical Requirements:

•Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.
•Specific vision requirements including reading of written documents and use of computer monitor screen frequently. 
Working Conditions and Environment:

•The position will be stationed in an office environment
•Flexibility required to work outside normal working hours of 8:00 a.m. " 5:00 p.m.
•Travel 10-15% as required 
About Catalent 
Catalent offers rewarding opportunities to further your career " join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients globally. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients around the world.
Catalyst + Talent. Our name combines these ideas. From drug and biologic development services, to delivery technologies to supply solutions, our highly skilled and dedicated global team of over 9,500 is passionate about improving health and wellness by combining their personal expertise and advanced technologies to advance science and supply products of the highest quality to customers and patients around the world.
Our VISION is to be the worlds most trusted, reliable and innovative drug development and delivery partner by upholding the highest industry standards and exceeding customer expectations while driving strong, sustained growth for the company.
Our MISSION is to develop, manufacture and supply products that help people live better, healthier lives.
OUR VALUES are at the foundation of everything we do:

•Patient First:  We put patients at the center of our work to ensure the safety, reliable supply and optimal performance of our products
•Customer Dedication: We strive to exceed our customers expectations every day
•People: We are committed to the growth, development and engagement of our people
•Innovation: We develop and apply innovative solutions, superior technologies and continuously improved processes
•Integrity: We demonstrate respect, accountability and honesty in every interaction
•Excellence: We have a passion for excellence in everything we do. 
Catalent. More products. Better treatments. Reliably supplied.

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