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Sharp Services · 1 day ago

Senior Manager, Quality Assurance

Allentown

Full-time

Onsite

Senior Level

7+ years exp

Sharp Corporation is a contract pharmaceutical packaging facility, and they are seeking a Senior Manager of Quality Assurance to lead QA teams and ensure compliance with quality standards. The role involves overseeing quality-related activities, troubleshooting issues, and driving continuous improvements while maintaining customer relations and regulatory compliance.

Health CareLife Science

Responsibilities

Leads one or more QA teams associated with designated functional areas of Packaging Operations or Central functions (i.e., Facilities, Engineering, Warehouse, Packaging Services, Incoming Inspection, Documentation, etc.)

Responsible for ensuring products and processes meet customer, company and regulatory requirements/standards and participating in internal, regulatory and customer audits as required

Responsible for delivering internal and customer quality KPIs and standards for assigned areas

Responsible for leading and coaching teams through problem-solving initiatives and impact assessments associated with change management and non-conformances as well as the review and approval of quality related documentation

Serve as an escalation point for customers and serve as backup for the site Quality lead during absences

Summarize data, draw conclusions, and turn recommendations into clear actions which can be effectively communicated across all levels of the organization

Identify and lead implementation of continuous improvement opportunities of broader impact (i.e., site or division level)

Support designated area to ensure compliance to processes and products and ensure testing, inspection and monitoring programs meet all requirements

Responsible for implementation of initiatives related to quality systems gap resolutions as well as quality improvements

Responsible for contributing to and driving attainment of the short- and long-term quality strategy by understanding the future needs, relative to the required skills and resources needed, to successfully support the business

Responsible to work across the broader quality organization to meet future needs through succession planning, training, development and mentoring of personnel

Responsible to effectively communicate a variety of personnel actions, including but not limited to, employment, termination, performance, discipline, scheduling, and salary review

Performs other related duties as required. by management

Qualification

Quality AssuranceFDA regulationsPharmaceutical industry knowledgeQuality systems implementationChange managementPlanning skillsWritten communicationOral communicationOrganizational skills

Required

Bachelor's degree in science is preferred with seven to ten years of related experience or Associate's degree with ten to fifteen years of related experience or a minimum of fifteen years of related experience

Knowledge of current FDA regulations and current industry practice

Thorough knowledge of quality and/or operations required

Above average written and oral communication skills required

Above average organizational and planning skills required