Assoc. Dir, External Quality

Job Description

An amazing opportunity has arisen for an External site Quality Lead. The incumbent is accountable for all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/ methods in conformance to all applicable regulatory requirements, regulatory filings, and company policies.

The incumbent also ensures that effective and robust Quality systems are followed to comply with required regulations, policies and guidelines governing the External manufacture of materials for the Company (e.g., small molecules active pharmaceutical ingredients, intermediates, raw materials) through direct oversight, support and technical advice, counselling to site leadership, and on-site supervision. The Associate Director may serve as a subject matter expert for EQA and Division in specific Quality systems, technology platforms, regulatory expectations and/or EE management, and can represent the Company in forums on their area of expertise (both internal & external).

This position can be located within India

Amount of Travel Required: Ability to travel up to 25%, occasionally on short notice.

What you will do:

Bring energy, knowledge, innovation, and leadership to carry out the following:

• Exhibits our company Leadership Behaviors and provides a leadership example for the team.
• Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.) both domestic and foreign.
• Maintains and provides expertise on EQA systems, tools, data, and processes on an ongoing basis.
• Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.
• May sponsor the interpretation and aggregation of financial/business data for EQA and highlight concerns as appropriate to EQA Management. Identifies and facilitates resolution of major deviations from financial or strategic plans.
• Accountable for oversight of an EE involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.
• Accountable for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight. These components may include review of batch documentation and deviation investigations.
• Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews. This also includes building effective quality systems at the EE and continuous improvement activities.
• Operates in a safe and efficient manner and in compliance with the Safety and Health Policy.

Minimum Education and Experience Required:

• Bachelor’s degree of Science (BS) in Pharmacy, Chemistry, Chemical Engineering or equivalent preferred with ten (10) years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.

Required Skills and Experience:

• Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.
• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.
• Communicates in English, both verbally and in writing.
• Moderate level of contractual and financial awareness. Previous experience participating in regulatory inspections. Be conversant with all domestic and foreign regulations and compendia governing plant operations.

Preferred Skills and Experience:

• Experience in auditing of pharmaceutical industry or compliance at a manufacturing site
• Strong critical thinking and analytical mindset
• Mature and open minded

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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):

Required Skills:

Preferred Skills:

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.
  

Requisition ID:R354763