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Meet the new Merck. A stronger pipeline. More products to help people in more ways. More passionate than ever about what matters to our customers.
Merck and Schering-Plough are now one company. We recently merged to create a stronger, more diverse and more truly global company. This not only benefits our company and our shareholders, but it also benefits the millions of people around the world who rely on our products and expect us to continue to deliver exceptional value.
The Supplier Quality Assurance Manager will be a member of a cross-functional team within the Supplier Quality Assurance group, managing relationships with suppliers of key components used in producing Merck's vaccines and pharmaceutical products. Duties will include, but will not be limited to:
- Along with Supplier Quality Assurance counterparts in Procurement and Science & Technology, serves as a primary point of contact to the suppliers. Responsible for coordination, oversight, problem solving and communication on matters related to the GMP status with the suppliers. Must be conversant with all regulations and compendia (domestic and foreign).
- Acts as a liaison of contact between suppliers and internal Merck site personnel.
- Tracks and monitors supplier operational and quality performance. Escalates supplier issues to the Director, Supplier Quality Assurance.
- Assures that the Supplier Quality Assurance department operates within established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.), both domestic and foreign.
- Manages activities associated with the Coordinator, Supplier Quality Assurance.
- Assures the development and maintenance of Quality Agreements, specifications, standards and AQLs with suppliers. Provides input into the development of contractual agreements with the suppliers.
- Works directly with senior management at the suppliers to resolve quality and supply issues as well as providing overall quality improvements.
- Executes a program of calibrated Quality oversight based on the component/raw material risk profile, capabilities, and quality/compliance performance of the suppliers.
- Responsible for Quality Assurance and control functions to include direct support to suppliers, coordination and oversight for component and/or raw material testing for qualification purposes.
- Provides assistance to suppliers for atypical investigations and change control.
- Responsible for maintenance and oversight of ongoing performance management to include regulatory inspection support and monitoring, internal complaint management, internal customer feedback coordination, and review of annual product reviews.
- Reviews all audit outcomes pertaining to suppliers and ensures appropriate and timely corrective actions were warranted.
- Monitors efforts to improve the suppliers' quality and reliability through ongoing oversight and formal communication programs and forums.
- May act as or support the regulatory compliance liaison on Merck's behalf to interface with regulatory Agencies relating to suppliers and/of components and raw materials.
- Provides support and develops presentations for Quality Council and Supplier Quality Assurance leadership meetings. Provides oversight for presentation content / issuance of minutes.
- Leads coordination of significant investigations including Fact Findings and regulatory communications.
- Participates in external benchmarking and internal voice of customer analyses for best practices management.
- Authors technical documents such as Policies, Procedures, Guidelines and assists in the development of the Supplier Book of Knowledge.
- Partners with Supplier Quality Assurance Procurement and Science & Technology managers to provide efficient and effective solutions to current supplier and/or site problems.
- Provides coverage and assumes the grant of authority in the absence of the Director, Supplier Quality Assurance. Works directly with the Vice President of MMD Quality Assurance and GMP Compliance on select projects.
- Travels to supplier locations to develop and manage the supplier/Merck relationships. Travel expectation is ~ 10% to 25%.
- Remote work arrangements may be available and will be evaluated on a case-by-case basis and with consideration for business needs.
Qualifications Education:
- BS/BA degree in an Engineering, Science, or Business field.
Required:
- Minimum 6 years experience in commercial, business, quality, technical or manufacturing operations functions.
- Must have strong demonstrated interpersonal and communication skills. Must have demonstrated personal networking and relationship building skills. Ability to work independently with all levels of the organization is required.
- Familiarity with regulatory requirements that govern GMPs (e.g. CFR and Eudralex).
- Travel to supplier locations to develop and manage the supplier/Merck relationships is a key enabler of success with this position. The travel expectations are ~ 10% to 25%.
- Experience writing SOPs, Policies, and/or Guidelines.
- Ability to use Microsoft Excel to enter data and use formulas to calculate information.
- Experience developing PowerPoint slides and delivering presentations to management.
- A key responsibility of this position is to serve as the primary point of contact for coordination, oversight, problem solving and communication with MMD's suppliers. Must have tangible experiences, either internal or external to Merck, associated with relationship building and networking.
Preferred:
- Technical writing skills, and experience with data management, collection and analysis.
- A strong knowledge of and broad experience in Quality Assurance.
- Experience in conducting or participating in atypical process investigations is preferred, as working with suppliers to resolve problems and implement corrective actions using problem solving techniques is a key expectation.
- Experience developing process flowcharts and using Microsoft Visio.
- Familiarity with the MMD Quality Management Systems (QMS).
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
To be considered for this position, please visit our career site at www.merck.com/careers to create a profile and submit your resume for requisition # QUA001949. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.
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Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
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