Quality Assurance Manager

3 days ago

Tempe, Arizona, United States West Pharmaceutical Services Full time
Job Summary

We are seeking a highly skilled and experienced Quality Assurance Manager to lead our quality assurance strategy across the West, Arizona site. As a key member of the Site Leadership Team, you will oversee the elements of quality operations, quality control, and quality system functions to ensure compliance with regulatory requirements and customer expectations.

Key Responsibilities
  • Develop and implement quality assurance plans and systems to ensure commercial manufacturing, development programs, and NPI programs remain compliant with all applicable regulations and guidelines.
  • Lead the Quality Assurance, Quality Engineering, Quality Systems, and Quality Program teams to ensure effective quality management and continuous improvement.
  • Collaborate with cross-functional teams, including Program Management, Operations, Engineering, and Continuous Improvement, to drive business objectives and ensure operational excellence.
  • Develop and maintain strong relationships with regulatory bodies and authorities to ensure compliance with local and regional guidelines and regulations.
  • Establish and monitor quality key performance indicators (KPIs) and communicate progress to the organization and senior management.
  • Manage the customer satisfaction process and lead improvements to overall customer satisfaction if discrepancies are identified.
  • Direct and oversee the facility readiness for all third-party audits, including notified bodies.
  • Lead alignment and standardization of best practices and enterprise excellence across all West sites producing customer or West-owned platform devices.
  • Play a key role in global enterprise quality documentation updating, including leading updates as necessary.
  • Inspire innovation and quality excellence, ensuring this culture is deeply ingrained and sustained in the organization's DNA.
  • Lead by example and set the highest standards in employee engagement and communication.
  • Champion talent development, ensuring commitment to local and global programs.
Requirements
  • Bachelor's Degree in pharmacy, chemistry, biology, or equivalent.
  • Significant experience (10+ years) in medical device/pharmaceutical manufacturing, quality assurance, regulatory affairs, or a related field.
  • Experience in regulatory compliance management, including familiarity with FDA and other regulatory agency requirements.
  • Proven track record of implementing process improvements and ensuring compliance with regulatory standards.
Preferred Qualifications
  • Regulatory skills: In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines, and other relevant regulatory requirements.
  • Leadership skills: Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.
  • Communication skills: Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
  • Analytical skills: Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.
  • Adaptability: Flexibility and adaptability to navigate changing regulatory landscapes and business priorities.
  • Ethical standards: Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.

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