Job Summary
The Manufacturing Quality Assurance Manager is responsible for oversight of all quality assurance activities, as defined by the quality management system, applicable FDA regulations, ISO requirements, current and future certifications / accreditations and Management. Responsible to provide support and guidance to Quality Assurance associates. Advises Management on necessary continuous improvement efforts so that systems and processes are in line with overall company strategy, voice of the customer, regulatory standards, guidelines and quality policy. Strategically provides technical input and advises / implements necessary process and documentation changes. Makes decisions based on customer, associate and company best interests. Lead strategic Quality activities to support the Manufacturing group.
MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)
Acts as Management Representative for manufacturing quality. Manages and provides direction to Quality Assurance department and associates. Trains, motivates, monitors and evaluates performance of Quality Assurance department and associates. Direct CAPA program (currently knows as NCR) and Lead Auditor to ensure CAPA and audit programs (internal and external) are performing effectively and timely. Lead Regulatory / 3rd party and customer audits, including audit preparation, documentation, follow-up, and closure. Conduct internal 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 the Quality Management Systems (QMS); maintain QMS software. Provide technical support regarding the revision or implementation of process documentation, including procedures, work instructions, and forms. Have working knowledge of and support compliance with ISO 9001 and other regulations as required. Maintain the integration of ISO standards and any other regulatory bodies, into the Quality Management System (QMS). Evaluate and advise management on current regulations and standards, new regulations and/or standards and proposed changes. Provide strategic insight to senior management. 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 event. Create, implement, and maintain process improvements, key initiatives, projects, and tasks, as assigned. Conduct root cause analysis throughout the Manufacturing group. Ensure organizational QMS training is in place; provide training as requested. Prepare, conduct, and advise necessary training on quality assurance concepts and tools. Lead Complaint Investigation efforts. Conduct periodic review of complaint process, audit program, and related quality programs. Maintain and manage at defined levels of compliance. Ensure work product and technical reports provide clarity and accuracy. Work directly with customers and suppliers to understand and communicate critical features, requirements and corrective actions, as well as supplier approvals and performance. Coordinates objectives with production procedures in cooperation with other managers to maximize product reliability and minimize costs. Insures inspection activity for product throughout production cycle. Performs other duties as assigned. QUALIFICATIONS (Education/Training, Experience and Certifications)
Bachelor’s Degree in a life science discipline, or an equivalent combination of education and experience; formal training and/or advanced courses are preferred 7+ years progressive work experience in Quality Systems, combined with a demonstrated record of accomplishments as a Quality professional, and with strong customer orientation in a similar industry; previous supervisory experience required KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
Must be familiar with relevant regulations Strong knowledge of FDA and international Quality System rules and regulations Strong oral and written communication skills Strong interpersonal and organizational skills Ability to take initiative, maintain confidentiality, meet deadlines, and lead people in a team environment essential PC skills required (MS Word, Excel, PowerPoint, Access) ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)
Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level. Although the associate primarily works in an office environment, while performing the duties of this job, the associate can be exposed to an industrial warehouse environment. The associate may work near moving mechanical machinery and/or vehicles and the noise level in the work environment can be loud. 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. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs. 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.
EEO Statement
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
OFCCP EEO Supplement
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
