Sr. Manager Quality Assurance

Juncos - Puerto Rico

Monthly Salary: Not Disclosed

Experience Required: 8years

Posted on: 16 hours ago

Vacancies: 1 Vacancy

Job Summary

Responsible for providing quality leadership governance and expertise in Quality Assurance processes related to the manufacture. Ensure compliance with 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.

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.
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 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 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 KPIs and Change Request 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 learnings across West e.g. system and technology best practices and harmonization / standardization.

Requirements

BS Engineering (Mechanical Chemical or Manufacturing) and 10 or more years of experience.
Strong knowledge of FDAs 21 CFR Part 820 ISO 13485 ISO9001 and other international regulations.
Experience in Project Management.
Experience in regulated industry such as pharmaceutical and medical device.
Previous leadership experience.

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.
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 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 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 KPIs and Change Request 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 learnings across West e.g. system and technology best practices and harmonization / standardization.

Requirements

BS Engineering (Mechanical Chemical or Manufacturing) and 10 or more years of experience.
Strong knowledge of FDAs 21 CFR Part 820 ISO 13485 ISO9001 and other international regulations.
Experience in Project Management.
Experience in regulated industry such as pharmaceutical and medical device.
Previous leadership experience.