SUMMARY:

The Manager, Strategic Quality Initiativessupports enterprise-level Global Quality transformation and quality systems initiatives that strengthen compliance, advance quality maturity, and improve organizational effectiveness across the business. This role works within Global Quality leadership and contributes to strategic initiatives related to quality culture, quality systems harmonization, and global Pharmaceutical Quality System (PQS) modernization.

The individual in this position partners closely with Global Quality leadership, site quality teams, and cross-functional stakeholders to support project execution, continuous improvement efforts, governance activities, and regulatory awareness. The role requires strong project coordination, analytical capability, a continuous improvement mentality and effective communication skills, as well as the ability to influence a global, matrixed environment without direct authority.

In this role, success means helping Global Quality initiatives move forward efficiently and effectively using smart thinking and identifying smart solutions, combining critical analysis with technological solutions.  The individual will bring structure to complex projects, and support PQS improvements that strengthen compliance and business performance across the organization.

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

The following is a list of minimum responsibilities related to the Strategic Quality Initiatives Lead position. Other duties may also be assigned.

 Global PQS Maturity and Continuous Improvement

• Contribute to the design, implementation, and delivery of key business and

quality initiatives in support of the PQS.

• Serve as a subject matter resource for assigned Pharmaceutical Quality System elements.

• Prepare for Global Management Review and drive related governance activities by developing internal trend summaries, regulatory intelligence inputs, and supporting materials.
• Identify emerging compliance themes, regulatory risks, and opportunities for continuous improvement; support continuous improvement activities affecting PQS.
• Support the development, revision, harmonization, implementation and governance of Global Quality Standards, and related procedures.
• Partner with site quality teams to promote understanding and consistent application of Global Quality requirements.

Project Support and Strategic Initiatives

• Support multi-site special projects and strategic initiatives assigned by Global Quality leadership including cross-functional improvement efforts related to compliance, inspection readiness, quality systems, and PQS maturity.
• Coordinate project activities, timelines, deliverables, and follow-up actions for quality and transformation initiatives.
• Represent Global Quality on internal working groups and project teams as needed.
• Prepare executive-level status updates, summaries, and presentation materials for senior leadership.

Communication

• Prepare and distribute a quarterly Regulatory Intelligence Newsletter for internal audiences.
• Prepare targeted regulatory intelligence briefings for senior leadership and subject matter experts as needed.

QUALIFICATIONS:

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Strong working knowledge of a PQS and GxP regulations.
• Ability to translate complex regulatory information into clear, concise, and actionable communication.
• Excellent written and verbal communication skills, particularly for non-specialist audiences.
• Strong analytical, critical-thinking, and organizational skills.
• Ability to manage multiple priorities and support cross-functional projects in a global, matrixed organization.
• Ability to work independently while collaborating effectively with stakeholders at multiple levels.
• Comfortable interacting with senior leadership and influencing without direct authority.
• Proficiency in Microsoft Office suite.
• Experience with Veeva or a similar electronic QMS platform preferred.

SUPERVISORY RESPONSIBILITIES:

None

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:

Education

• Bachelor’s degree in a scientific, life sciences, or health-related field (required).

• Advanced degree such as MS, preferred.

Experience

• 10+ years of experience in pharmaceutical quality, regulatory affairs, compliance, or quality systems.
• Experience in global contract manufacturing, regulated operations, or complex supply chain environments preferred.
• Experience supporting global or multi-site quality programs preferred.
• Experience supporting management review, executive reporting, governance activities, or inspection readiness efforts preferred.
• Experience supporting quality transformation, QMS harmonization, or enterprise improvement initiatives preferred.

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. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Primarily office-based with occasional time in operational or manufacturing environments, as needed.
• Approximately 10% travel between sites may be required.
• Valid driver’s license required, if applicable to site travel expectations.

DISCLAIMER:

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.