Nature and Scope:

Reporting directly to the Vice President of Quality Affairs, the Quality Affairs Sr. Director serves as a key strategic leader with comprehensive responsibility for setting and driving the highest standards of quality across all phases of production and testing of small molecule sterile injectable and lyophilized products, cytotoxic large molecule sterile injectable and lyophilized products, pre-filled syringes (PFS) and combination products. This role is accountable for establishing and maintaining rigorous compliance with all regulatory requirements and quality systems, ensuring excellence in laboratory operations, documentation, and management of Regulatory Body Inspections (e.g., FDA, EMEA, Health Canada, etc.). The Quality Affairs Sr. Director will champion strategic quality initiatives, spearhead continuous improvement processes, and cultivate a culture of quality throughout the organization. This position is expected to demonstrate strong leadership and influence at all organizational levels, both domestically and internationally, serving as a visible role model for operational excellence and compliance.

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 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, Document Control, Annual Product Review Systems, Technical Services and External Clients.

• Responsible for Quality Control Functions (Stability, Chemistry, Microbiology, EM & QC Particulate) for the site.

• Manage and improve ARI's processes 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, Annex 1, and other regulatory requirements.
• Identify and facilitate the resolution of quality issues in conjunction with cross functional site teams.
• Manage all aspects of regulatory authority inspections, 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 standardization of policies and procedures.
• Drive quality Culture and Core Competency Model initiatives in support of enhanced organizational performance.
• 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 required.

• Minimum 12 years leading functional quality assurance; quality control, compliance, and manufacturing quality operations required.

• Expertise across multiple areas leading quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities, validation for pharmaceutical manufacturing facility expansion, Tech Transfer, new product launches.
• 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.

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.