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.
- 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.
- Oversee Label Design team.
- 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, ISO 13485 and FDA Quality System Regulations (QSR); Maintain the integration of FDA regulations and 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.
- Guide Management Review preparation and lead semi-annual meetings. Advise Executive Management where data should be captured and appropriate metrics to ensure strategic objectives are met.
- Conduct periodic review of complaint process, audit program, and related quality programs.
- Maintain and manage cGMP at defined levels of compliance.
- Insure 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.
Experience & Skills:
- 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)
- Bachelors 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
Environmental Working Conditions & Physical Effort:
- 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.
Avantoris a global manufacturer and distributor of high-quality products, services and solutions to professionals in the life sciences and advanced technology industries. As our channel brand, VWR offers an integrated, seamless purchasing experience that is optimized for the way our customers do business. Operating from over 30 countries worldwide, the company seeks to enable customer success in the biopharmaceutical, pharmaceutical, medical device, diagnostics, healthcare, educational, industrial, government, aerospace & defense, and semiconductor industries. For more information visitwww.settingscienceinmotion.com.
Resume Submissions To VWR From Third Party Recruitment Firms Will Not Be Considered
VWR is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
VWR maintains a drug free workplace.
VWR is a US Federal contractor.
VWR and design are registered trademarks of VWR International, LLC. VWR International, LLC is aware of fraudulent e-mails referencing VWR job opportunities. Please note: VWR does not hire employees through e-mail solicitation and never requests any employee to cash money orders or send money to others. If you question the validity of a job, please visitjobs.vwr.com.
For more information on VWR please visitwww.vwr.com.
Job Posting Date: 2018-08-21