Senior Director Quality Affairs

Nature and Scope

Reporting to the Senior Director of Quality is a multi-disciplinary management role that will interact with all phases of production for the manufacture of sterile injectables. This position is responsible for oversight and direction for all aspects of compliance including laboratory operation, documentation, Regulatory Body Inspections (e.g., FDA, Health Canada, etc.), supplier quality, third party manufacturer quality, as well as strategic quality initiatives and continuous improvement processes. This position will interact with all levels of the organization both domestically and internationally.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Provides Leadership and direction for a professional team focused on quality management systems and compliance; establish and maintain performance goals, training plans, and provide regular feedback including performance plans and reviews.
• Perform all duties in accordance with American Regent's Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.
• Quality Management Ownership for Deviation, CAPA, Change Control, Documentum Control, Annual Product Review Systems, Technical Services and External Manufacturers (CMO's).
• Lead Quality activities to execute production records, approve executed batch records, and support release of product for shipment.
• Manage and improve ARI's Quality Systems to ensure compliance with regulatory requirements and provide safe and effective products to customers.
• Ensures site wide cGMP compliance in accordance with 21 CFR Parts 210 and 211, USP requirements, and other regulatory requirements.
• Identify and facilitate the resolution of quality issues in conjunction with site teams.
• Manage all aspects of regulatory authority inspections, and customer and corporate audits, development of responses, and execution of required improvements following such inspections/audits.
• Own and support metrics-based Continuous Quality Improvement activities and Key Performance Indicators (KPI) through application of statistical methodology.
• Provide oversight for review and release of commercial, R&D, and clinical study products.
• Responsible for maintaining and managing communications and cross-functional activities with internal/external customers and regulatory agencies.
• Responsible for continuous improvement initiatives for the site and working with other ARI locations to assure best practices and harmonization of policies and procedures.
• Drives quality Culture and Core Competency Model initiatives in support of enhanced organizational performance.
• Responsible for Quality Control (Stability, Chemistry, Microbiology, EM, & QC Particulate labs) for the site.
• Manage and facilitate the QA Operations, QA Inspection and Finishing team to assure timely and quality oversight of production activities related to production, manufacturing, filling and transfers, inspection and packaging of sterile injectable drug products.
• Partner with Production, Regulatory Affairs, Engineering, R&D and QA Compliance to strategize and organize implementation of new technology, processes and products.
• Lead on-site QA activities in investigating deviations, CAPAs, or other compliance issues associated with daily inspections/packaging operations.
• Write and revise SOP's and other cGMP documentation.
• Ensure all work is performed and documented in accordance with existing company policies and procedures, as well as cGMP and health and safety requirements.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelors in Life Science or equivalent course of study required. Master's Degree is a plus.

• Minimum 15 years progressive experience in pharmaceutical operations and interactions with regulatory agencies.

• Minimum 10 years leading functional quality assurance; quality control, compliance, or manufacturing operations.

• Expertise across multiple areas including developing quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities, validation for pharmaceutical manufacturing facility.
• Understands the standards and principles of Compliance and Quality Assurance including the specific regulatory requirements and techniques of examining, questioning, evaluating and reporting to determine a quality system's adequacy and deficiencies.
• Must have a thorough understanding of applicable regulations/guidelines/expectations and have a proven ability to apply them to a Pharmaceutical environment.
• Proven excellence in written and verbal communication skills.
• Proven record of exceptional people and program management skills.
• Ability to work independently and deliver timely results.
• Ability to work off hours and weekends as needed.
• Able to travel 10% of the time.

Physical Environment and Requirements

• While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.

• Employee must be able to occasionally lift and/or move up to 25 pounds.
• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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