Associate Director - Quality Leader, External Site

Job Description

The External SiteQuality Leader (ESQL) is accountable for providing Quality Oversight over one or more External Entities that manufactures or tests cell banks, biologic drug intermediates, biologic drug substances, or biologic drug products or both on behalf of our Company's Manufacturing Division. Activities include the broadest possible involvement in every aspect of manufacturing and testing operations related to the quality and compliance of products produced.

• Accountable for oversight of an External Entity (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 | Components may include review of batch documentation and deviation investigations.
• Assist in managing the end-to-end processes of transfers including but not limited to: Due Diligence, Feasibility Studies, Protocols/Reports, PPQ, PAI Readiness and Quality System Oversight Implementation.
• Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews | Includes building effective quality systems at the EE and continuous improvement activities.
• 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.

This position reports to the Quality Operations Director, Large Molecule Drug Product, for general advice and instruction concerning Quality Operations, but functions independently, and provides guidance as needed to team members in the Product Quality Manager role.

Education Minimum Requirement and Experience:

• Bachelor of Science degree (BS) in a Science, Engineering, or related area of study with seven (7) 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; OR
• Master of Science degree (MS) in a Science, Engineering, or related area of study with five (5) 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 Experience and Skills

• Experience with manufacturing operations and/or analytical expertise associated with biologics and/or vaccines. Aseptic manufacturing experience.
• Competent in analyzing complex product, production and testing issues and have demonstrated scientific problem solving capabilitiescapabilities.
• Strong and principled interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.
• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.
• Works independently, receives minimal guidance.
• Communicates in English both verbally and in writing.

Preferred Experience and Skills:

• Direct experience with managing external partners (CMOs, Labs, etc.)
• Experience in batch disposition, deviation management, change control and participating in regulatory inspections.

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

Pay Transparency Nondiscrimination

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's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

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".

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected salary range:

$135,500.00 - $213,400.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed 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:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Requisition ID:R278627

PDN-9b3078aa-496e-40a0-8a34-f6e9b2b0b5ac