Sr Quality Manager

West Pharmaceutical Services-posted 2 months ago

Full-time

Cidra, PR

5,001-10,000 employees

Miscellaneous Manufacturing

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At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Cultivate a positive working relationship with internal and external stakeholders by supporting validation in design and development, specification development, and execution of manufacturing programs in line with agreed standards.
Accountable for the development of the quality assurance plans and systems to ensure commercial manufacturing, development programs and NPI programs remain compliant with all applicable regulations and guidelines.
Oversee regulatory agency interaction related to compliance to local and regional guidelines/ regulations.
Develop strong internal and external relationships with regulatory bodies and authorities.
Develop and champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.
Ensure QA resources have the adequate training, education, competency, and experience to perform their GMP related job functions effectively.
Develop a culture of risk activities in the development and maintenance of product/ process risk and hazard analysis.
Coach, mentor and lead highly dynamic team members to help achieve the requirements of this position as well as the individual career goals of team members.
Responsible and accountable for quality departmental budget.
Play a role as a key contributor to documentation updating, including leading any updates.
Participate in and drive compliance to global harmonization initiatives.
Responsible for quality data trending e.g., CAPA, Deviations, Customer Complaints, Product Quality KPI's and Change Requests and driving quality improvements.
Ensure all Quality and Regulatory correspondence (internal and external) is aligned and compliant with West policies and guidance.
Act as a mentor and coach to the business with respect to Quality and Regulatory knowledge.
Foster and encourage shared learnings across West e.g., system and technology best practices and harmonization / standardization of West Procedures and practices.
Perform additional duties at the request of the direct supervisor.

Bachelor's Degree in Engineering or related disciplines (mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering) required.
Minimum 10 years related experience required.
Previous leadership experience, preferably managing remote employees, preferred.
Experience in regulated industry such as pharmaceutical and medical device, preferred.
Project Management experience preferred.

Strong knowledge and understanding of FDA's 21 CFR Part 820, ISO13485, ISO9001, and other international regulations.
Familiarity with document management databases, particularly MasterControls and SAP.
Proven ability to manage multiple priorities, drive projects to completion and meet internal customer expectations.
Ability to effectively communicate with co-workers and business partners at all levels of the organization (both internal and external).
Excellent organizational skills with an ability to think proactively and prioritize work.
Working knowledge of statistical data analysis.
Thorough understanding of validation activities and risk management principles and techniques.
Strong problem-solving and critical thinking skills.
Medical industry or highly regulated industry experience.

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