Srm/Manager, External Manufacturing Quality

Job Description

The primary purpose of the position is to help ensure that all products or materials, with a primary focus on Aqua products, supplied to Animal Health from a set of key contract manufacturers and commercial warehouses are manufactured, packaged, analyzed, and distributed in conformance to company and regulatory guidelines and meet both internal and external customer demands.

The incumbent is responsible for supporting the total quality performance and operations of such Third-Party Operations through direct support and technical advice, guidance, and counseling to the site Quality Operations Manager or Director. The incumbent exercises a coaching role in guiding the Third Party to comply with Current Good Manufacturing Practices regulations and other pertinent legal requirements.

Responsibilities:

• Reports to the External Manufacturing Quality Lead - China (Animal Health) and is a member of the Quality External Manufacturing team primarily supporting third-party activities in Asia countries such as China, Thailand, Korea, etc. Receives guidance and direction when necessary but may also be required to operate independently. Keeps the Regional Quality Lead informed on the status of operations and when challenges, opportunities and/or issues arise.
• Assures that the partner operates within the agreed upon GMP policies and procedures (or other applicable regulations) and in accordance with the Quality elements of the Commercial Agreement and the Quality Agreement; ensures the Quality Agreements are kept up to date and ensures review of the Quality elements in the Commercial Agreement
• Acts as AH Quality Operations point of contact to defined key suppliers and as the Quality liaison between the external partner and the internal company personnel.
• Supports Animal Health audit plans and effective execution of subsequent remediation by the partner; may also perform separate audits
• Conducts regular site visits to support training and coaching to initiate quality improvements within the partners' Operations where necessary.
• Assures Quality requirements on Change Proposals submitted by the partners conform to all requirements.
• Reviews all Deviation investigations submitted by the partners and supports further investigation where necessary.
• Support Product Quality Complaint (PQC) investigations with the relevant suppliers
• Support Technology Transfer projects for the relevant suppliers
• Assures guidance is provided to the partner in the preparation of Quality Systems, procedures and guidelines as applicable
• Support effective preparations at the third party for regulatory inspections (where required).
• Effectively contributes to cross-functional investigations and project teams.
• Review batch documentation and data to support batch release activities when appropriate
• Maintains Quality metrics as required
• Completes additional Quality related activities as required to fulfill the role

Minimum Requirement

• At least Bachelor degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent)
• Must have at least 10 years of expertise and broad experience in Quality Systems, Quality Assurance, and Quality Control including solid knowledge of global GMP and regulatory requirements
• Must have both Chinese and English language capability
• Must have excellent problem-solving skills, based on science, facts, data, and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management principles;
• Must have the ability to influence the management of complex manufacturing operations, protecting company image and reputation with patients, medical stakeholders, and regulatory agencies.
• Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, sterile operations, cGMPs, and regulatory issues
• Must have strong demonstrated interpersonal, communication, negotiation, persuasion, and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Able to handle organizational complexity and ambiguity
• Must have the ability to travel globally approximately 50% of the time

Preferred Skills

• Preferable to have auditor training (for example ISO 9001)
• Advantageous to have Qualified Person eligibility
• External engagement in regulatory or industry forums.
• Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.
• Demonstrated ability to lead and drive results/impact for critical business/compliance initiatives.
• Demonstrated ability for process improvement and to create/implement simple, compliant systems in a diversity of areas.

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Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

• At least Bachelor degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent)
• Must have at least 10 years expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements
• Must have both Chinese and English language capability
• Must have excellent problem solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management principles;
• Must have the ability to influence management of complex manufacturing operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies.
• Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, sterile operations, cGMPs and regulatory issues
• Must have strong demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Able to handle organisational complexity and ambiguity
• Must have the ability to travel globally approximately 50% of the time.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:08/31/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R298973