Job Description

Our company manufactures products that are predominantly utilized to eradicate cancers globally. In recent years, countries around the world have enacted new or expanded product programs, which has created an unprecedented increase in global demand. The manufacturing facility in Durham will play a critical role in the network of life-saving medicines and vaccines.

The Associate Director, Quality Systems and Compliance provides expertise in the coordination of resources and equipment pertaining to qualification/validation activities supporting our product and facility expansion.

GENERAL PROFILE:

• Ability to work independently and as a member of a team.
• Manages individual contributors (professional employees), as applicable.
• Contributes to the performance and results of the expansion project.
• Adapts plans and priorities to address resource and operational challenges.
• Decisions are guided by policies, procedures and/or business plans.
• Provides technical guidance to employees, colleagues, or clients.
• Anticipates and interprets client and/or customer needs to identify solutions.
• Ability to provide off shift and weekend support during critical processing and manufacturing.

FUNCTIONAL EXPERTISE:

The Associate Director, Quality Systems and Compliance will be responsible for comprehensive management of all activities required to successfully support Process Performance Qualification (PPQ) and routine manufacturing to include the following:

• Responsible for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as our policies and procedures.
• Responsible for establishing processes that ensure required safety guidelines are followed.
• Review and approve qualification/validation documents for equipment and process (i.e. IQ/OQ/PQ).
• Review and approve Performance Qualification documents pertaining to environmental monitoring and process qualification.
• Provides Quality input, direction, and approval of Quality Notifications (QNs) and Change Requests (CRs). Author, review, and approve SOPs.
• Assume project management opportunities, by leading and participating in process improvement, learning events, or business support initiatives, as guided or approved by Quality management.
• Train employees on new or revised processes or procedures.
• Review and approve BOM changes and Master Batch Records.
• Review and approve Operations, Technology, or Automation protocols.
• Leads or actively participates in project suite teams, as required.
• Direct support of regulatory inspections and audits.
• Direct support of validation activities and all other associated Quality functions.
• Other duties as requested by Management.

PROBLEM SOLVING:

• Independently supports resolution of technical and operational problems through collaboration with peers.
• Applies appropriate risk management while adhering to cGMP requirements.
• Makes decisions guided by policies and procedures that impact the team’s ability to meet performance objectives.
• Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes.

QUALIFICATIONS:

Minimum Required Education and Experience:

• Bachelor’s degree in Biology, Biochemistry, Chemistry, or other relevant discipline with seven (7) years’ experience in pharmaceutical operations, technical services, and/or quality operations. OR
• Master’s degree in Biology, Biochemistry, Chemistry, or other relevant discipline with five (5) years’ experience in pharmaceutical operations, technical services, and/or quality operations.

Required Experience and Skills:

• A Minimum of 3 years in a quality function.
• Previous investigation and CAPA experience, Batch Record Review, Validation IQ, OQ, PQ, Change Control.
• Product, Raw Materials and Components Release.
• Has in-depth knowledge of cGMPs and domestic and international regulatory requirements.
• Is expected to possess a high degree of problem-solving ability.
• Must have demonstrated ability to independently manage multiple high level/ priority projects, ensuring timely completion.

Preferred Experience and Skills:

• Clinical manufacturing experience
• Drug Substance Manufacturing
• Electronic Batch Records (MES)
• cGMP experience in a sterile, bulk or finished pharmaceutical environment
• Experience with process or environmental monitoring performance qualification
• Experience with SAP or MRP/ERP systems
• Experience with SAP, IPI and/or GLIMS
• Flexibility to support on-call and hyper-care activities

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:

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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:

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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.

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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”.

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:06/25/2024

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:R300503