Director, Quality and Regulatory Affairs | GenomeWeb

Director, Quality and Regulatory Affairs

Organization
Catalent Pharma Solutions
Job Location
St Petersburg, FL
Salary
Benefits
Job Description

Accountable and responsible for managing all aspects of Quality Operations, including Quality Control, Quality Assurance, Regulatory Affairs, Validation, and GMP/Technical training, representing a staff of approximately 100 associates. Included in the functions are: sampling testing (analytical and microbiological), and release of all products; administration of the stability program; primary contact with all regulatory agencies, to include, but no limited to FDA, DEAand MHRA; primary point of contact with all suppliers and customers on quality and regulatory issues. Responsible for ensuring the site is in compliance with cGMP guidelines adherence to Catalent Corporate Quality Policies and applicable Catalent Pharma Solutions quality standards across the business. Reports directly to the VP, Quality Oral Technologies and maintains an administrative reporting relationship to the General Manager, St Petersburg, FL.

III. Specific Activities, and Responsibilities:

(A concise list of the key responsibilities of the job.)

Organization

- Oversees all aspects of Quality Assurance, including GMP principles of Production Record Audits, in-process quality, investigation of batch deviations and in-process quality events and change control for production records.

- Primary point of contact for regulatory agencies such as, but not limited to FDA, DEA, MHRA, ANVISA and all other regulatory agencies as applicable.

- Responsible for regulatory affairs activities, including preparation and maintenance for DMF?s and responding to regulatory inquiries from customers and regulatory agencies.

- Oversees the internal GMP compliance audit program and the supplier audit/qualification program.

- Effectively manages the Quality budget and the Operational Excellence programs within Quality.

- Responsible for regulatory compliance functions, including SOP Systems, CAPAs, Training Program and Annual Product Reviews.

- Responsible for implementing safety and security procedures in Quality and Quality Contorl Operations.

- Facilitates and directs the sampling, testing and release of raw materials in accordance with activities defined within the Quality Control laboratories and approved specifications. Organizes the talent required to develop and maintains test methods and specifications forl raw materials.

- Facilitates and directs the sampling, testing and release of l in-process, finished products and stability samples in accordance with activities defined within the Quality Control Laboratories and approved specifications.. Organizes the talent to develop and maintains test methods and specifications for all finished products.

- Team Development

- Partners with business unit leaders to ensure high product quality, regulatory compliance and business results.

- Partners with manufacturing to establish programs and an operating environment based on continuous improvement in all areas of the operation.

- Ensures effective staffing of the Quality Operations function.

- Ensures that employees in Quality Operations are effectively trained according to cGMP principles, technology, site operating procedures and Catalent Quality policies.

- Ensures the Managers and Supervisors in Quality are being developed and an effective quality performance management system being executed through quarterly reviews.

- Oversees the implementation of semi and annual performance reviews, merit increases and bonus allocations for qualified individuals with the Quality Operations with effective rewards and recognition programs in place.

- Maintains a cross business team orientation across other business units of Catalent as appropriate.

Analysis and Information Management:

- Reviews production and sales forecast statistics in order to plan for future activity.

- Reviews statistical information on quality performance in order to identify and implement corrective actions.

- Assembles statistical information for the purpose of planning quality activities, improvements and cost reductions.

- Responsible for authenticity and timeliness of all Quality reports.

Primary Location
United States-FL-St Petersburg

Organization
Softgel Technologies

Schedule
Full-time

Requirements:
Qualifications

- 4 year life science degree required; graduate degree would be preferred

- 10 years pharmaceutical industry experience

- 6-8 years management experience

- Multi departmental experience would be advantageous

Knowledge/Skills Requirements: (Unique knowledge skills, or problem-solving requirements.)

- Must possess solid technical expertise as it relates to manufacturing processes, decision-making skills, and the ability to solve problems with minimal guidance.

- Ability to identify root cause of problems and offer solutions, which address causes, rather than symptoms.

- Ability to effect change in a positive environment.

- This individual must be able to provide constructive arguments and sound justification as it pertains to technical and compliant requirements in accordance with the Code of Federal Regulations when liaisons with other departments and QA decisions are required.

- Strong knowledge of DEA, Regulatory Affairs and Product Development requirements is preferred.

- Must possess strong technical writing skills and be able to speak effectively before of internal and external groups and customers as well as corporate leadership members.

Physical/Mental Requirements: (List any special requirements to be able to perform job.)

Ability to work extended hours or off-hours as required. Individual may be required to sit for long periods of time, while reading documents. The individual may also be required to stand or walk. Ability to work effectively under pressure with constantly changing priorities and deadlines.

Business Environment: (Describe conditions under which work is performed.)

Office environment. Employee may be present on the manufacturing floor occasionally and/or as needed. The noise level in the work environment is usually quiet.

About Catalent

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,500 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in Fiscal 2013 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com

More products. Better treatments. Reliably supplied.?

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives:

Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Job
Quality/Regulatory

Requirements
About Our Organization

The GRE isn't a good predictor of graduate school performance or productivity, according to two PLOS One studies.

Bitesize Bio has some advice for scientists ready to leave their current lab behind.

A trio of editors from the Nature family of journals describes what make a peer review a good one.

Spots in genetic counseling training programs are competitive, Maclean's reports.