Job Description

EXTERNAL QUALITY ASSURANCE - PRODUCT QUALITY MANAGER \xe2\x80\x93 Specialist The Product Quality Manager is responsible for ensuring that all products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with company expectations and all applicable regulatory requirements. Role has primary batch release responsibility and ensures that effective and robust Quality Systems are in place to comply with required regulations, policies and guidelines governing the External Party manufacture and release of API intermediates and APIs by means of risk-based quality oversight and on-site supervision, as appropriate. What you will do: Bring energy, knowledge, innovation and leadership to carry out the following:

• Evaluate and/or release products to other sites with the assurance that the goods were produced in conformance to all applicable policies, procedures and compliance with all governing regulations; review and approve changes to master batch record.
• Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Finding
• Provide support for audits of External Party by internal audit teams and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are implemented.
• Conduct routine analytical change requests and support process modification change controls.
• Annual Product Review Assembly
• Provide support in the preparation of metrics, procedures and Quality Agreements
• Provide proactive support to initiate quality improvement projects.
• Track and monitor operational and quality performance of the External Manufacturer/ partner, responsible for shipment under quarantine.
• Assist shipments of reference standards to External Manufacturer sites
• Support routine process validation
• Prepare pre-PAI assessments, support document requests for regulatory filings and post approval changes.
• Occasional site visits to build relationships and monitor efforts to improve the External Manufacturer\xe2\x80\x99s quality and reliability through ongoing oversight and formal communication programs and forums.

Background:

• Degree in Science, Engineering or any relevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).
• Previous experience in the pharmaceutical industry with some knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred, for a minimum of 1- 2 years.

Skill & Competencies needed:

• Solves range of straight forward problems
• Receives moderate level of guidance and direction.
• Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goal.
• Responds to non-standard requests from clients and/or customers; investigations with assistance from others as needed.
• Explains information and persuades others in straightforward situations.
• Accountable for technical contribution to project team or sub-team; may manage/lead a small project team.
• Ability to work across boundaries, developing interpersonal, relationship building and leadership skills.
• Communicates easily in English and Chinese, both verbally and in writing, in support of the External Manufacturer sites associated with this role.
• Knowledge of External Manufacturing Management, Supply Chain, Operations
• Experience with COMET SAP is preferable.
• Experience with batch record review and batch release process
• Previous experience in audit support and deviation management

Travel: Ability to travel up to 10% of the time. Our Human Health Division maintains a \xe2\x80\x9cpatient first, profits later\xe2\x80\x9d ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide. Who we are \xe2\x80\xa6 We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world\'s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for \xe2\x80\xa6 Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us\xe2\x80\x94and start making your impact today. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another\xe2\x80\x99s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: Travel Requirements: 10% Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s):
Requisition ID:R235521