"Alerted.org

General Description:

Senior Director, Business Process Owner (BPO) for GxP processes, with a specific focus on **Validation and select Manufacturing** processes within the **Quality Management System (QMS)** will be accountable for the global design, implementation, and continuous improvement of these critical processes. You will serve as the subject matter expert (SME) and strategic leader driving compliance, efficiency, and a culture of quality throughout the enterprise. This role ensures QMS processes are aligned with international regulatory standards (e.g., FDA, EMA, ISO 13485, ICH Q10 / E6) and business objectives.

Essential Functions of the job:

+ Own the Validation and Manufacturing-related QMS processes, ensuring their effectiveness, integration, and compliance across global operations.

+ Lead the design, implementation, maintenance, and continuous improvement of validation and manufacturing process elements in the QMS.

+ Define and maintain clear process documentation, including procedures, templates, and work instructions.

+ Demonstrate technical expertise for assigned processes, staying up-to-date of new approaches & practices

+ Establish and monitor KPIs and metrics to evaluate process performance and compliance.

+ Guide CAPA investigations related to validation and manufacturing activities and ensure robust root cause analyses.

+ Actively lead cross-functional collaboration, promoting seamless integration of QMS processes across business units.

+ Deliver training programs to build global process knowledge and capabilities.

+ Represent your process areas during regulatory audits, inspections, and management reviews.

+ Identify and drive opportunities for digital transformation, automation, and efficiency within the QMS.

+ Establish and manage a user community focused on validation and manufacturing QMS processes to foster knowledge-sharing and best practices.

+ Perform other responsibilities as assigned.

Supervisory Responsibilities:

+ NA

Skills and Qualifications:

+ Advanced degree in life sciences, engineering, quality management, or related field

+ 12+ years of progressive leadership experience in quality management within a regulated industry (pharmaceutical, biotechnology, or medical devices).

+ Proven experience with QMS implementation and process ownership.

+ Deep expertise with Valiation (equipment, process, cleaning, etc) and Manufacturing processes within the GxP/QMS framework.

+ Deep understanding of quality management principles, regulatory frameworks, and industry standards (e.g., ISO 13485, ICH Q10 and E6).

+ Excellent communication, negotiation, and stakeholder management skills.

+ Strong analytical and problem-solving skills.

+ Proficient in data analysis, project management, and quality improvement methodologies (e.g., Lean, Six Sigma).

+ Ability to communicate complex information clearly and effectively across business functions

Travel:

+ Up to 20% internationally

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.