Job Information
Momentive Performance Materials Inc. Quality Systems Manager, Pharma in Abingdon,
Job Title: Quality Systems Manager, Pharma
Summary:In this impactful role, you will l be responsible for driving quality across our site. You will oversee the modernization and compliance of our Quality Management System (QMS) to ISO 9001 standards and beyond. Partnering with our Global Quality Center of Excellence, you will ensure our site's QMS is best-in-class. You will champion continuous improvement initiatives that elevate our quality standards. As the internal audit program leader, you will identify areas for growth and drive positive change. By fostering a culture of quality through collaboration with site leadership and teams you will make a significant impact.
Responsibilities Include:
Align with the company strategic plans and business needs
QMS/Pharma Leader is responsible:
to implement global QMS processes, procedures, and policies
for document creation and maintenance with linkage to global QMS and functional documents
to develop objective evidence that site processes conform with ISO9001 and other quality standard, and accreditation requirements
to ensure effectiveness of the site QMS
implement site QMS Management Reviews
to develop and implement site QMS objectives aligned with global objectives
to develop and execute internal audit plans including coordinating with Global Quality COE
to ensure site registrar audits are scheduled and completed
to respond to external quality audits
to maintain sufficient number of cross-functional internal auditors
to assist site personnel to respond to audit findings, as needed
Manage a Food Safety Team and organize its work
Monitor and report on the performance of the site QMS and on opportunities for improvement to site and Quality COE
Promote customer focus throughout the site
Ensure that the integrity of the QMS is maintained when changes to the QMS are planned and implemented within the site
Maintain documents, document system, and action tracking system
Maintain and train employees in the use of the Quality and compliance software system used across the organisation for document management
Own the review of GMP Production Batch records and perform final release activities
Maintain data integrity in Gensuite ATS for the site
Provide support to Site Quality Leader regarding
Concerns from Site Leader
Training needs
Possible measures of effectiveness
Alignment with other sites
sharing findings globally
Continuous Improvement
Drive improvement of site QMS
Drive standardization of site processes
Lead improvement site projects
Training and Mentoring
Provide ISO Auditor Training, as needed
Provide Root Cause/Corrective Action training, as needed
Provide Gensuite ATS and Compliance Calendar training, as needed
Identify and provide other training, as needed
Keep up to date with national and international legislation, guidelines and customer practices with respect to GMP
Identify and communicate emerging trends in our customer base regarding expectations of adherence or compliance to industry specific Quality standards and accreditations, beyond ISO.
Work with Site Quality Leader to determine adoption of other standards or responses to customers.
Facilitate external audits from both customers and external certification bodies and follow up corrective actions as needed.
Qualifications:
The following are required for the role
Undergraduate degree or equivalent experience
5+ years’ experience in Manufacturing, Quality, or related roles within a regulated industry, such as pharmaceutical or medical Devices
Qualified Internal and Lead Auditor for ISO9001 and other external quality standards
Experience in the definition, planning, and management of Quality Management systems in highly regulated markets
Strong track record of working effectively as an individual contributor as well as in a cross-functional team of both peers and site management
Effective interpersonal skills, including good listening ability and the capability to convince others to establish or change precedents
Ability to work effectively in a matrix organization and in cross-cultural environments. Willing to join global calls/meetings outside of normal business hours as needed.
Able to develop and deliver effective training programs to all levels of the organization
Proficient in Microsoft Office Suite
The following are preferred for this role
Business or technical degree preferred
Quality Improvement tools experience, i.e. Lean Six Sigma, Root Cause Corrective Action methodologies, etc.
Ability/desire to develop expert knowledge of the SAP QM functional module
Good communication skills in English
Good Excel and Minitab skills for data analysis.
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What We Offer:
At Momentive, we value your well-being and offer competitive total rewards and development programs. Our inclusive culture fosters a strong sense of belonging and provides diverse career opportunities to help you unleash your full potential. Together, through innovative problem-solving and collaboration, we strive to create sustainable solutions that make a meaningful impact. Join our Momentive team to open a bright future. #BePartoftheSolution
About Us:
Momentive is a premier global advanced materials company with a cutting-edge focus on silicones and specialty products. We deliver solutions designed to help propel our customer’s products forward—products that have a profound impact on all aspects of life, around the clock and from living rooms to outer space. With every innovation, Momentive creates a more sustainable future. Our vast product portfolio is made up of advanced silicones and specialty solutions that play an essential role in driving performance across a multitude of industries, including agriculture, automotive, aerospace, electronics, energy, healthcare, personal care, consumer products, building and construction, and more.
Momentive believes a diverse workforce empowers our people, strengthens our business, and contributes to a sustainable world. We are proud to be an equal opportunity employer . Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any characteristic protected by law.
To be considered for this position candidates are required to submit an application for employment and be of legal working age as defined by local law . An offer may be conditioned upon the successful completion of pre-employment conditions, as applicable, and subject to applicable laws and regulations .
Note to third parties: Momentive is not seeking or accepting any unsolicited assistance from search and selection firms or employment agencies at this time.
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