Avantor, Inc. Sr Manager Quality, Global Services in Pennsylvania
Job SummaryThe Sr Manager Quality – Global Services is responsible for providing management of Quality systems and personnel for all Therapak/Biostorage Services sites globally. Responsible for the administration of the Quality Assurance (QA) and Quality Control (QC) programs and ensures compliance with the Quality Manual, as well as, all applicable regulations and standards for which Therapak/VWR is certified.
MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)
Oversee and ensure Quality Assurance program, Quality Assurance leadership and associates. Attend to and guide inspections as required.
Oversee systems that affect quality of product.
Oversee field actions including product advisories and product recalls.
Provide support regarding the revision or implementation of the documentation of these systems, including procedures, work instructions, and forms.
Direct CAPA program and support activities to ensure CAPA and audit programs (internal and external) are sound.
Ensure customer audits, including audit preparation, documentation, follow-up, and closure are well managed. Participate when required
Conduct audits for Quality Management System (ISO/QSR).
Support supplier evaluation program, including supplier audit program. Review program and advise Purchasing where issues exist.
Oversee the application of business Quality Management Systems.
Provide technical support regarding the revision or implementation of process documentation, including procedures, work instructions, and forms.
Interface with customers and Regulatory agencies (FDA, DEA, etc) regarding on-site quality audit activities and customer Quality Agreements.
Evaluate and advise management on current regulations and standards, new regulations and/or standards and proposed changes. Provide enterprise-wide strategic insight to senior management.
Maintain the integration of FDA regulations and ISO standards into the Quality Management System (QMS).
Support and advise necessary continuous improvement projects as a result of periodic trend reporting; management review; complaint investigation; supplier, customer, and internal audits; and any other relevant quality events. Use Six Sigma, Lean Manufacturing and any other ABS methodologies to drive quality system improvements.
Create, implement, and maintain process improvements, key initiatives, projects, and tasks, as assigned.
Deploy effective root cause analysis enterprise-wide.
Provide training as requested. Prepare, conduct, and advise necessary training on quality assurance concepts and tools.
Consult with Sales on viability and capabilities of new products. Understand product workflow; follow product from start to finish, ensuring finished good meets written expectations/specifications. Review design process of finished goods as it relates to customer specifications.
Lead Complaint Investigation efforts as required, including managing weekly meetings and reviewing prior to closure.
Conduct periodic review of complaint process, audit program, and related quality programs.
Support validation program.
Coordinate and support ETQ Reliance Software based on Global Compliance Direction.
Performs other duties as assigned.
QUALIFICATIONS (Education/Training, Experience and Certifications)
Bachelor’s Degree in a life science discipline ore related is required
Advanced degree or certification preferred
10+ years of related experience working in a regulated industry (medical devices, API, pharmaceuticals, etc.) preferred
5+ years of experience in managing others in regulated industry.
Multi-site experience a plus
KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
Good interpersonal and people management skills. Ability to lead and motivate personnel; and cultivate a team mentality
Strong working knowledge of ISO 9001, ISO 13485 and FDA Quality System Regulations (QSR)
Ability to interact with all levels of the organization
Functional knowledge of Microsoft Outlook, Word, and Excel, (or equivalent), highly desired
Previous exposure and experience with automated inventory control systems strongly recommended.
Demonstrated knowledge and experience with software systems and integration with the quality system.
Strong communication skills – verbal and written
Demonstrated knowledge of production process and prioritization in one or more business units
Ability to prioritize required functions, ensure on time completion of required tasks, and manage time effectively.
Ability to liaise with different departments to ensure all business and process related tasks are compliant with regulatory requirements and daily Quality needs are met facility-wide
Strong analytical and problem solving skills
ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)
Works in an administrative area thermostatically controlled to room temperature with adequate lighting and ventilation.
May work a portion of the day on the production floor thermostatically controlled to room temperature with adequate lighting and ventilation and with occasional elevated noise levels. May work a portion of the day in a general warehouse environment with adequate lighting and ventilation with occasional elevated noise levels and a varying range of temperatures.
Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
A frequent volume of work and deadlines impose strain on routine basis.
Minimal physical effort is required; however, the job position does require frequent walking, standing, bending, reaching, lifting or possibly carrying objects weighing up to 30 lbs.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, skills, efforts or working conditions associated with a job.
DISCLAIMER:The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.Avantor is proud to be an equal opportunity employer.
We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at TalentManagement@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision using the links below.
EEO is the Law (https://media.vwr.com/emdocs/docs/EEO-is-the-law.pdf)
OFCCP EEO Supplement (https://media.vwr.com/emdocs/docs/OFCCP-EEO-Supplement.pdf)
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
3rd party non-solicitation policy
By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation
Avantor® is a leading global provider of integrated, tailored solutions for the life sciences and advanced technology industries. Strengthened by the recent acquisition of VWR, the Company is a trusted partner to customers and suppliers from discovery to delivery. With operations in more than 30 countries and a diverse portfolio that includes more than four million products, Avantor enables customer success through innovation, cGMP manufacturing and comprehensive service offerings. Collectively, we set science in motion to create a better world.
Learn more at www.avantorsciences.com