Sr Quality Manager (Cidra, Puerto Rico, US)

Job Summary

Responsible for providing quality leadership, governance, and expertise in Quality Assurance processes related to the manufacture of West products. Ensure compliance to regulatory requirements and West procedures. Proactively develop, lead, and drive the execution of the Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external stakeholders. Champion advocacy for product, process, and system quality, and drive continuous improvement within the Quality Management System.

Essential Duties and Responsibilities

• 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. All the while ensuring that West’s product quality and reliability meets or exceeds customers’ expectations.
• 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.
• Responsible for ensuring QA resources have the adequate training, education, competency, and experience to perform their GMP related job functions effectively. Ensure sufficient support in place to support programs and flawless transition into Operations.
• Responsible for developing 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 achieved 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.
• Ensures all Quality and Regulatory correspondence (internal and external) is aligned and compliant with West policies and guidance.
• Acts as a mentor and coach to the business with respect to Quality and Regulatory knowledge.
• Fosters and encourages shared learning’s 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.

Education

• Bachelor's Degree in Engineering or related disciplines (mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering) required.

Work Experience

• Minimum 10 years related experience required and
• Previous leadership experience, preferably managing remote employees. preferred and
• Experience in regulated industry such as pharmaceutical and medical device. preferred and
• Project Management experience preferred

Preferred Knowledge, Skills and Abilities

• 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

Physical Requirements

Additional Requirements

• Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
• Excellent written and oral communication skills
• Medical component and device manufacturing require strict adherence to standards.
• Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams
• Read and interpret data, information, and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Demonstrates enthusiasm, takes accountability, and drives for results.
• Superior organizational and leadership skills with ability to help team grow and thrive
• Able to lead and front multiple third party Medical Device / Pharmaceutical audits.
• Able to interact with global Medical Device / Pharmaceutical agencies in support of queries / product launches.
• Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820, ISO14971
• Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention. Must have a proven track record of developing and maintaining positive customer relationships.
• Able to lead and manage the performance of a multi-functional team.
• Able to organize and prioritise tasks, must be detail orientated and self-motivated.
• Have excellent written and verbal communication skills. Must be able to work in a fast paced environment.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to always comply with the company’s safety and quality policy