Senior Director Quality Systems

Nature and Scope

The Senior Director, Quality Systems will be responsible for leading the development, alignment, implementation, and maintenance of a robust Quality Management System (QMS) that ensures compliance with Good Manufacturing Practices (GMP) and other regulatory requirements across multiple manufacturing sites.

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.

• Provide strategic leadership and direction for GMP processes and QMS. Create and organize short- and long-term compliance goals in alignment with ARI’s business strategy.

• Monitor and interpret regulatory changes and industry trends related to GMP, aseptic and sterile pharmaceutical manufacturing. Ensure the company’s GMP practices follow current regulations and industry standards.

• Oversee the planning, execution, and documentation of internal audits.

• Prepare for and support regulatory inspections and audits.

• Oversee Supplier Quality Management.

• Conduct risk assessments and ensure appropriate controls are implemented.

• Establish weekly, monthly, quarterly, and annual Management Review Board metrics as required to support the business.

• Provide effective leadership including individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating team members of the functional area.

• Assists in the training of new and existing staff to ensure that they are well versed with the QMS standards and policies.

• Responsible for managing and implementation of programs in concert with ARI’s cultural initiatives.

• 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.

• Bachelor's degree in Life Sciences or equivalent course study Required. 

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

• Minimum of 10 years of people management within a human and animal health pharmaceutical environment experience required with appropriate management level experience within human and animal health pharmaceutical environment. Must include experience successfully managing multi-disciplinary teams as well as multiple products.

• Demonstrated aptitude for effective leadership of staff.

• Proven track record of leading people and teams to achieve organizational goals in support of strategic plans, and ability to extend influence beyond span of control.

• Extensive knowledge of US GMP regulations and established expertise in Parenteral manufacturing, labeling, light inspection, packaging of aseptic/sterile liquid and lyophilized drug products. Non-Sterile manufacturing, labeling, and packaging experience is also a plus.

• Direct experience in both operations and quality assurance including CDMO oversight, internal site operations, and Supplier Quality Management.

• Experience in leading monthly and quarterly Quality Review Boards.

• Problem solving and analytical skills: Incumbent must be able to think analytically and provide timely compliant resolution to all issues/challenges that may occur.  

• Skilled in planning, budgeting, and financial analysis.

• Experience with Microsoft Office, and electronic quality systems (Trackwise, Veeva Vault, etc.) and in-depth understanding of Part 11 compliance to electronic documentation.

• Communication skills: Must be an active listener and speaker who can easily manage the flow of information and instructions.   Must also have experience effectively communicating with all levels of an organization.

• Possess exceptional organizational, interpersonal, and negotiation skills.

Physical Environment and Requirements

• Potential remote with up to 50% travel to all locations within the organization.

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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