Quality Manager

2 weeks ago

Garner, United States Orion Talent Full time

Position Details:

Title: Quality Manager

Location: Garner, NC

Shift: Mon – Fri, days

Compensation: $100k-$115k base salary, plus 10% bonus

Benefits: Comprehensive package includes Health, Dental, and Vision, 401(k) with company match, PTO includes vacation, sick leave, and floating holidays, Paid Leave (paid maternity leave for employees who qualify for FMLA, as well as parental leave), and tailor-made career development plans.


Position Description: looking for an accomplished Quality Assurance Manager to lead our commitment to quality, operational efficiency, and excellence at in Garner, NC. As the QA Manager, you will be responsible for developing, implementing, and maintaining a comprehensive Quality Management System and will play a key role in fostering a culture of quality, efficiency, and continuous improvement at the facility. Will grow and lead a Quality team of 4-6 Quality professionals. Ultimately, needs a strong people leader to manage/define/drive an effective Quality Management System and Quality team at the site in Garner. Currently investing in expansion of the site, and this is a great opportunity to advance cGMP, influence teams and deliver world-class quality to their growing portfolio of Pharmaceutical customers. The Quality Manager will report to the Regional Quality Manager and support the harmonization of QMS across all sites.


Responsibilities include:

• Develop, implement, and manage the site Quality Management System (QMS) that aligns with industry standards and organizational objectives.

• Facilitate quality and continuous improvement initiatives to enhance operational efficiency, customer satisfaction, and overall performance

• Lead all quality efforts at the plant to ensure that products consistently meet or exceed defined quality standards and customer expectations

• Collaborate with cross-functional teams to identify and implement quality improvements, drive process optimization, and achieve cost-effectiveness

• Ensure timely resolution and closure of Corrective and Preventive Action (CAPA) plans

• Conduct regular audits and assessments to evaluate the effectiveness of the QMS and processes, identifying areas for improvement

• Analyze quality performance data and metrics to identify trends, develop insights, and drive data-driven decision-making

• Establish and monitor key performance indicators (KPIs) to track the effectiveness and efficiency of quality processes and continuous improvement initiatives

•Ensure site adheres to local regulations and industry standards for pharmaceutical packaging and printing

•Provide training and mentorship to employees to enhance their understanding of quality principles, practices, and methodologies

•Oversee supplier quality management, including supplier evaluations and audits, to ensure the quality of incoming materials and components

•Represent the facility in dealings with external stakeholders related to quality and continuous improvement

•Assist the General Manager in driving a culture of quality excellence, continuous improvement, and accountability

• This role will have supervisory responsibilities over the Quality Department, and it is expected that this individual will have previous experience leading successful teams


Requirements:

• Bachelor's degree in related field (e.g. Business Administration, Quality Management, Engineering) is preferred, or 15+ years of related experience

• Minimum of 5 years of quality management experience within the printing, packaging or pharmaceutical industries, with a proven track record of improving quality standards and processes in a complex manufacturing environment

• Expertise in ISO 9001 (Quality Management Systems) and ISO 15378 (Primary Packaging

Materials for Medicinal Products) standards. QMS expertise is a must – ISO 15378 is nice to have, but can be learned

• Expertise with FSC, SFI, and PEFC environmental certifications and system maintenance a plus

• Ability to manage direct reports and lead teams to drive quality improvements and

standardization efforts

• Understanding of pharmaceutical industry regulations, including cGMP, FDA, and international

quality standards

• Strong analytical skills with the ability to analyze data, identify trends, and implement effective

solutions

• Excellent communication and interpersonal skills to lead and collaborate with cross-functional

teams, direct reports, and stakeholders

• Proficiency in quality management systems, data analysis tools, and software applications

• QCBD Software Experience a plus – understanding what a good QMS looks like is a must

• Relevant certifications such as Certified Quality Manager (CQM) or Certified Quality Auditor

(CQA) are advantageous

• Lean Six Sigma certification a plus

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