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SUMMARY / OBJECTIVE

The Manager provides strategic leadership and oversight for quality and validation operations related to commissioning, qualification, and validation (CQV) activities at Sovereign Pharmaceuticals. This role drives compliance excellence, ensures regulatory alignment, and fosters a culture of continuous improvement within the pharmaceutical manufacturing environment. With deep expertise in validation requirements, the Manager proactively shapes validation strategies, mentors teams, and collaborates cross-functionally to enhance operational efficiency and quality standards.

ESSENTIAL FUNCTIONS

· The Manager is a leader in developing the quality operational strategy and execution plans for site compliance related functions for risk assessment, qualification, and validation activities (e.g., Process Validation, Equipment and Analytical Instruments Qualification, Computer System Validation (CSV), Cleaning Validation, Method Validation).

· Assist in the implementation of global quality initiatives.

· Create and implement a quality roadmap that includes best practices, quality vision strategy, policies, processes, and procedures that will drive and improve business performance and are compliance with current Good Manufacturing Practices (cGMP), Good Automated Manufacturing Practice (GAMP), and Sovereign's SOPs.

· Expert knowledge of regulations and guidance's (e.g., 21 CFR part 11, 21 CFR part 210, 21 CFR part 211, ICH, ISPE, PDA, MHRA, PIC/S).

· Drive continuous improvement and preventive actions throughout the organization.

· Oversee the development of specifications (design requirements, functional requirements, and user requirements), trace matrices, validation summary reports, and test protocols for installation, operation, and performance under the guidance of the department management.

· Key point of contact for product technology transfers activities internally and externally, including transfer strategy, lead transfer protocol and reports, and risk assessments.

· Understands analytical laboratory data integrity and statistical treatment of experimental data. Can independently review and recognize laboratory data that is compliant to applicable regulations and meets study protocol acceptance criteria.

· Recruit, retain, train, develop, and lead the quality talent in support of the Technical Services Unit's strategy.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee may be required to sit at a computer or be on their feet for long periods of time. The duties will require working around and on manufacturing equipment requiring the use of ladders. There are specific vision abilities required by this position for Cleaning Validation activities. This job requires the need to be able to lift fifty (50) pounds.

POSITION TYPE / EXPECTED HOURS OF WORK

This is a full-time position. Days and hours of work are Monday through Friday but extended (earlier or later) work times or weekend work may be required. Validation activities require flexible hours to meet the manufacturing schedule.

REQUIRED EDUCATION AND EXPERIENCE

· Bachelor's Degree in a physical or an applied scientific discipline (e.g., Chemistry, Engineering) with a minimum of seven years of experience is required in areas of validation, qualification, and commissioning in the pharmaceutical industry. Experience in a leadership role is a plus.

· Demonstrated experience with developing, authoring, and execution of documentation including validation documentation, technical protocols, and technical reports.

· Demonstrated ability to facilitate and be an active participant on teams.

· Demonstrated knowledge of project management skills and techniques, ability to prepare timelines and schedules to ensure projects are executed on time and within budget.

· Knowledge of FDA Current Good Manufacturing Practices (cGMP) and Good Automated Manufacturing Practices (GAMP) requirements.

· Experience and Inspection interaction with FDA, EMA, or other regulatory agencies.

· Demonstrated proficiency in interpersonal communications, both written (technical writing required) and verbal.

· Demonstrated successful communication/collaborative skills, influencing skills, and negotiation skills to manage conflicting and multiple demands, opinions, and expectations including ability to facilitate meetings as well as present to various levels within an organization.

· Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint).

PREFERRED EDUCATION AND EXPERIENCE

· Bachelor of Science Degree in Chemistry or Engineering with a minimum of seven years of experience in areas of validation, qualification, and commissioning in the pharmaceutical industry.

· Experience in a leadership role.

· Demonstrated experience with developing, authoring, and execution of Design of Experiments protocols to determine critical parameters for processes.

· Has significant knowledge of the key scientific, technical, and regulatory challenges associated with the manufacture of non-sterile pharmaceutical solid and liquid oral dosage forms.