- Lead, manage and develop qualified staff to ensure effective execution of tasks, cGMP compliance, and to attain operational and development goals.
- Drive improvement in customer experience - complaint reduction, supply reliability, field actions, audit performance, etc.
- Ensure that products meet quality standards.
- Provide sound quality input to validation planning and execution, including R&D product transfers.
- Provide support to Engineering and Operations groups in troubleshooting and development of process technology and continuous improvement programs. Utilize sound statistical based facts to bring value to the customer.
- Drive product and process improvements through thorough investigations and effective root cause analysis. Drive risk mitigation and effective process controls.
- Develop and implement standardized metrics that guide actions and promote continuous improvement (e.g. FPQ, CAPA, etc).
- Implement and maintain tracking and trending to identify potential out of trend conditions and proactively mitigate.
- 5% domestic and international travel.
- Bachelor Degree in a STEM discipline
- 3+ years' experience leading a quality organization in a manufacturing setting with proven track record of successful performance
- 3+ years' experience developing organizational vision and supporting goals and objectives with proven track record of driving successful change initiatives that have resulted in favorable business outcomes
- 3+ years' experience working with customers and internal/external stakeholders from different geographies
- Black Belt or Green Belt
- Advanced degree (MS, MBA, or PhD)
- CQE, CQA, CMQ/OE, CQPA
- Experience with ISO & FDA regulations (such as 21 CFR 820, 210 & 211)
- Proven strong leadership skills w/ ability to motivate, inspire, and build a high performing team. Demonstrated ability to drive "followership".
- Ability to manage in a complex, matrixed, and fast paced environment. Able to triage workload effectively to drive departmental focus.
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Quality Manager - Jaffrey - Merck Group
Description
Work Location: Jaffrey, New Hampshire
Shift:
Department: LS-SC-UJFB US Jaffrey QA Admin
Recruiter: Paul Therrien
This information is for internals only. Please do not share outside of the organization.
Your Role:
The Quality Manager plans and maintains activities to ensure product reliability and conformance to cGMP, as well as Customer/Regulatory specifications. The Quality Manager works as a collaborative team member and leader to establish department goals and objectives to drive business results and a continuous improvement culture. This quality group supports the overall operations team, a 750million franchise, made up over 500 manufacturing personnel producing approx. 4000 SKU's.
Essential Job Functions:
Minimum Qualifications:
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
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