Quality Assurance Manager
4 weeks ago
Job Summary:
We are seeking a highly skilled Quality Assurance Manager to lead our quality assurance strategy across the West Pharmaceutical Services site. This role will oversee the elements of quality operations, quality control, and quality system functions, ensuring alignment with business objectives and operational objectives.
Key Responsibilities:
- Develop and execute quality assurance plans and systems to ensure commercial manufacturing, development programs, and NPI programs remain compliant with all applicable regulations and guidelines.
- Direct and oversee the Quality Assurance, Quality Engineering, Quality Systems, and Quality Program teams.
- Lead regulatory agency interaction related to compliance to local and regional guidelines/regulations and develop strong internal and external relationships with regulatory bodies and authorities.
- Establish, monitor, and provide weekly/monthly progress of the Quality KPIs and communicate it to the organization and senior management.
- Responsible and accountable for quality departmental budget.
- Accountable for the final disposition of product and for the decision on final batch release of medical device components, sub-assemblies, and combination products.
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.
- 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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