Sr Mgr, Quality Assurance

West Pharmaceutical Services•Cidra, PR

7d•Onsite

About The Position

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. Job SummaryThis onsite position is 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.

Requirements

Bachelor's Degree Preferably in engineering, preferred disciplines could include mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering; required
Minimum 10 years relative experience required

Nice To Haves

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
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

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.