Director, Quality Systems

Summary

Monitor and control compliance within the organization including overall responsibility and decision-making for the areas of Document Control, Change Control, Notice of Events/CAPA, GMP Training, Compliance (DEA, FDA), Annual Product reviews, and customer complaints. Lead system simplification activities and actively participate in process mapping. Provide support to the VP, Quality for compliance activities, FDA interaction, and development of strategies for continuous improvement of product quality, compliance, and performance of Operations. Support company, operations, and departmental objectives to meet customer objectives for high quality products delivered on time, with no significant outstanding compliance or product quality concerns.

Essential Duties and Responsibilities

• Provide comprehensive formal and informal leadership to promote a positive work environment and communicate overall business expectations to working groups and staff members.
• Provide leadership, strategic insight, direction, and implementation for all Quality activities related to new product development, continued product improvement and compliance.
• Identify project needs and solutions. Create project timelines and track multiple projects, revising scopes of work when necessary.
• Oversee quality compliance of major business initiatives and system implementations.
• Lead Quality Council meetings and the delegation of resulting actions and/or CAPAs.
• Lead compliance sustainment for the organization, including oversight of third-party audits and FDA interactions, Field Alerts and Recalls.
• Prepare the organization and ensure readiness for inspections- FDA, third party, Pre-Approval inspections, etc.
• Lead and manage Internal Auditing, including corrective action follow-up and effectiveness.
• Initiate and manage Quality Agreements for vendors.
• Participate in the evaluation of systems and/or procedures to drive consistency, promote best practices and integrate within the organization.
• Oversee Laboratory practices and procedures to ensure compliance with applicable regulations, SOPs and methods.
• Lead key QS functions and personnel, including Document Control SOPs, forms, Master Batch Records, etc., Change Control, Notice of Events, CAPA, GXP Training, Compliance FDA, Customer Complaints, and Annual Product Reviews.
• Lead system simplification activities and actively participate in process mapping.
• Provide support to the VP, Quality to identify and achieve key company, operations, and departmental strategies, tactics, and objectives relating to product quality and cGMP compliance.
• Review and approve SOPs, Master Production and Packaging Records, and Process and Cleaning Validation documents.
• Direct employees; assign projects, review work product as necessary, and manage individual and team performance and development.
• Build and maintain a staff of professional, highly motivated and knowledgeable individuals. Participate in selection of personnel and provide for their effective and thorough training.
• Establish standards of performance in accordance with company guidelines and evaluate performance against those standards for all staff members, to include preparing and conducting performance evaluations.
• Manage interactions with contracted resources and consultants, as appropriate.
• Coordinate department resources versus scheduled projects, to include ensuring timely completion of projects and maximum utilization of department resources.
• Develop and maintain the department's Standard Operating Procedures, and related documents.
• Prepare routine departmental progress reports to upper management.
• Prepare and maintain departmental budgets and expenses.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Perform other related duties as assigned to meet departmental and Company objectives.

KNOWLEDGE/SKILLS/ABILITIES

• Demonstrated knowledge of Quality Assurance, Quality Control, Validation and pharmaceutical process improvement concepts and the ability to apply cGMPs.
• Proven leadership and interpersonal skills to effectively lead, influence, collaborate, and work with diverse teams and individuals at all levels throughout the organization.
• Highly organized with strong project management skills to effectively manage multiple priorities, projects and requirements in a fast paced, dynamic environment.
• Excellent communication skills to effectively communicate in a clear, concise manner whether in oral, written or presentation form.
• PC proficiency using Microsoft Office, with specific proficiency in Excel, Word, Access, and Project required.
• Demonstrated ability to work independently on complex problems and resolve technical issues.

• Flexible, with ability to handle and coordinate multiple projects in a dynamic, fast-paced environment.

EDUCATION/EXPERIENCE

• Bachelor's degree in Chemistry, Engineering or Science; or equivalent combination of Bachelor's degree and pertinent, progressive experience in pharmaceutical or other highly regulated industry.
• Minimum 10 years' pertinent, progressive experience with increasing levels of responsibility in the pharmaceutical industry with at least five years' experience directly leading others.
• Minimum five years' actual Quality experience with relevant dosage form products.
• Comprehensive knowledge and experience in the application of FDA regulations and guidelines.
• Experience hosting and leading in the preparation, management, and follow-up related to FDA inspections.

Work Environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

1. Stand, walk, sit, reach, talk, and hear.
2. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
3. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

1. Normal office conditions.
2. Occasionally in a proximity to moving mechanical parts, laboratory equipment and exposure to chemicals.
3. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

We are an equal opportunity employer M/F/D/V.

Current Openings for Director, Quality Systems Jobs at Nesher Pharmaceuticals (USA) LLC