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Senior Quality Manager

1 month ago

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

We are seeking a highly experienced Senior Quality Manager to lead our quality assurance strategy across the West, Arizona site. As a key member of the Site Leadership Team, you will oversee quality operations, quality control, and quality system functions to ensure business objectives are aligned and the company is performing to operational objectives.

This role requires a strong leader with excellent communication and analytical skills to drive process improvements and ensure compliance with regulatory standards. You will have a dotted line reporting relationship to the Director, Operations, Arizona to ensure development and alignment of the site business plan.

Key Responsibilities:

  • Lead the Quality function for combination medicinal products, investigational medicinal products (IMP), and medical device products and components moulded, assembled, and packed by West, Arizona to meet and exceed all regulatory requirements, customer requirements, and key performance indicators.
  • Direct and oversee the Quality Assurance, Quality Engineering, Quality Systems, and Quality Program teams.
  • Develop and execute the local quality strategy for the West Arizona campus, ensuring alignment to the global vision and strategy and defining quality objectives in line with overall Contract Manufacturing quality objectives.
  • Cultivate a positive working relationship with the West Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards.
  • Manage the customer satisfaction processes and lead improvements of overall customer satisfaction if discrepancies are identified.

Requirements:

  • Bachelor's Degree in either 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 Knowledge, Skills, and Abilities:

  • 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.

West Pharmaceutical Services is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.