Leads the implementation, maintenance and continual improvement of the site Quality Management System (QMS) and its performance. Leads high-impact projects that aim to optimize cost, quality, and operational performance. Serves as the primary site lead for continuous improvement, influencing leadership and partners to embed sustainable best practices. Mentors and guides other staff, providing expertise in advanced methodologies and change management. Acts as a key driver of operational excellence within the site.

Responsibilities

• Provides leadership for QMS, ensuring compliance with ISO, cGMP and corporate quality standards
• Provides root cause analysis and corrective/preventative action plan support to site leadership
• Reviews, CAPAs, spoilage incidents, and other errors for designated high risk accounts, and reviews and approves root cause analysis efforts by site leadership, and corrective/preventive actions to ensure the risk of repeat occurrence is reduced or eliminated.
• Oversees internal audits and QMS performance metrics, presenting findings to site leadership through regular Management Reviews
• Develops and deploys advanced process improvement methodologies to optimize cost, quality, and efficiency
• Leads improvement projects, including EHS program development and sustainability for assigned programs
• Monitors quality related training requirements, including maintaining an effective level of trained quality resources
• Ensures conformance with overall company standards relating to documentation and record retention.
• Assists in the identification, development, and implementation of proactive programs designed to reduce injuries.
• Provides expertise in EHS initiatives, including focus groups, safety programs, and change management.

Qualifications

• Bachelor degree in discipline related to functional work is required
• At least 5 years of relevant experience is required including overseeing ISO and cGMP.
• Able to apply broad work experience and knowledge when analyzing complex problems. Must be able to consistently identify critical elements, variables and alternatives to develop solutions. Must be able to organize/prioritize existing resources and incorporate new information, as needed, to implement the most effective solutions.
• Able to apply excellent business acumen and collaborative skills when resolving problems.
• Requires excellent communication skills with ability to state messages in a clear manner by using language that is easy for others to understand.
• Requires strong understanding of the impact of a message on the organization or customer.
• Possess an understanding of and practical application of computer systems, including Microsoft Windows and/or MAC environments, and the ability to leverage other technical tools to efficiently and accurately complete work assignments. This includes applying expertise across all relevant tools and applications and effectively mentoring junior team members in their use.
• Able to maintain organizational integrity with a strong grasp of document control standards.
• Strong leadership and communication skills and ability to work effectively across all employee levels.
• Demonstrated leadership, facilitation, coaching and organization skills.
• Internal Auditor or Lead Auditor qualification or experience required.
• Demonstrated knowledge of ISO related quality management systems required
• Demonstrated knowledge of and experience with cGMP and/or SOC2+ requirements preferred.

Additional Information

RRD's current salary range for this role is $73,500 to $116,000 / year. The salary range may be adjusted based on the applicable geographic location of the hired employee, and the range may change in the future. At RRD, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions may vary based upon, but not limited to education, skills, experience, proficiency, performance, shift and location. Depending on the role, in addition to base salary, the total compensation package may also include participation in a bonus, commission or incentive program. RRD's benefit offerings include medical, dental, and vision coverage, paid time off, disability insurance, 401(k) with company match, life insurance and other voluntary supplemental insurance coverages, plus parental leave, adoption assistance, tuition assistance and employer/partner discounts