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Job Description

Position Description:

Quality Assurance (QA) Senior Specialist - Large Molecule Analytical

We are seeking a quality leader for the role of Senior Specialist, Quality Assurance in the Large Molecule Analytical Sciences Quality group.

Large Molecule Analytical Sciences Quality is part of the Global Biologics Quality Organization and is responsible for technical, operational and strategic quality oversight of a growing and fast-moving large molecule pipeline. LMAS Quality is specifically focused on quality oversight for large molecule drug substance commercial support, Analytical Method Transfers, and analytical product lifecycle activities.

This position is responsible for the management, execution and leadership of quality activities to further the analytical product lifecycle of large molecule programs and to ensure compliance with cGMPs, applicable worldwide regulations, and our Company's requirements for supported area(s).

The Senior Specialist is also responsible for providing assessments to senior management as to the compliance status and risk posture of supported area(s) and guidance on alignment of policies and procedures with current regulatory expectations.

Responsibilities include but are not limited to:

• Remain informed of current GMP requirements and industry trends in the large molecule, analytical, areas to applicable worldwide regulations and industry standards. Provide comments on proposed regulations and communicate impacts to client areas using a risk-based, phase-appropriate approach for decision making. Maintain an expert level of knowledge related to specialized area of technical expertise, specifically for analytical areas

• Ensure departmental SOPs reflect departmental procedures and the current regulations. Responsible for oversight of SOPs in supported areas and ensure periodic updates, as appropriate

• Manage the review and/or approval of analytical GMP documentation for applicable regulatory filings, clinical supply, development, and technology transfer

• Represent the department or area on project teams or committees establishing GMP, or quality standards, policies or expectations within our Company

• Support a team of professionals to execute on quality oversight deliverables for large molecule drug substance analytical product lifecycle.

• Apply technical / quality expertise to help teams remove obstacles, overcome technical

• challenges, and make impactful clinical disposition decisions

• Review and approve analytical documents

• Collaborate with peer leaders in LMAS Quality Assurance to drive strategic initiatives and continuous improvement opportunities

• Contribute to establishment and sustainability of a safety first, compliance always culture

Primary skills include but are not limited to:

• Strong scientific/technical expertise in the commercial space, coupled with the ability to collaborate with subject matter experts

• Strong compliance knowledge and understanding of health authority regulations, and interpretation and application of GMPs within a commercial environment.

• Possess and apply large molecule drug substance technical knowledge (such as analytical method / development / transfer); demonstrated ability to share knowledge

• Ability to support cross-functional analytical initiatives

• Demonstrated experience with quality risk management.

• Strong cross-functional teamwork and collaboration skills

• Demonstrated ability to communicate (oral and written) effectively with diverse individuals / groups

Position Qualifications :

Education Minimum Requirement:

• Bachelor Degree in Engineering, Biology, Chemistry or related field.

Required Experience and Skills:

• A minimum of 8+ years of relevant experience working within the biologics and/or vaccines / pharmaceutical industry or advanced Degree with 5+ years of relevant experience.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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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:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

10/8/2024

*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.

Job Posting End Date: 10/08/2024

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: R314897