Manager, Quality Assurance (Night Shift))

Job Description

Our Company has constructed a new manufacturing facility to significantly expand its production capacity. Global demand has outpaced our current maximum manufacturing capabilities. Once this new facility is fully operational we will triple our current manufacturing capacity which is expected to support the anticipated demand for the foreseeable future. This investment reaffirms our Companys longstanding dedication to producing this medicine for the patients who need it. The facility will include end-to-end processing of drug substance drug product including biotech culture growth harvest lyophilization product inspection and quality control laboratories.

The Quality Assurance Manager will direct Shop Floor Quality Assurance (SFQA) B160 to support process and technology introduction compliance improvements and manufacturing readiness to initiate production of commercial product. The focus for the position includes all aspects of Shop Floor QA oversight supporting Third Shift/Night Shift (Sunday - Thursday 10:00 PM to 6:30 AM Shift. Require flexibility for Holidays and weekends.)

Responsibilities

• Reporting to the Quality Assurance Organization will independently manage Shop Floor Quality Assurance team on second shift.

• Lead a Shop Floor QA team to provide end-to-end QA support for Production Support & Media Drug Substance and Drug Product throughout the project lifecycle.

• Ensure all aspects of the Shop Floor QA proceed in compliance with cGMP regulations and our Companys Quality Management System focusing on batch record review process/aseptic observations critical site review critical alarm management environmental monitoring incursion/excursion response.

• Will support and prepare Set-up Activities for SFQA First Shift (Days).

• Support Operations and the Technical Operations Deviation Management groups with event assignments classifications investigations corrective and preventative actions reviews and approvals through current Quality Systems (e.g. CLUE and SAP).

• Support and maintain a Safety First Quality Always environment with participation in Site GEMBAs for Safety and Quality Compliance.

• Escalate and collaborate quality and compliance issues as needed through established site Tiers.

• Leads and Supports the Aseptic Observer Program (AOP) and Batch Record Review (BRR) workstreams for the SFQA Area.

• Makes decisions guided by policies and procedures that impact the teams ability to meet performance objectives and metrics. Consults on an as-needed basis with next level manager on more complex decisions.

• Actively sponsor and develop a culture that defines a High-Performing Organization including proactively providing developmental support coaching and assistance to team members.

• Support compliance to Durham Site policies and procedures that promote Permanent Inspection Readiness (PIR).

• Consults on an as-needed basis with next level manager on more complex decisions.

Minimum Required Education and Experience:

• Bachelors degree in chemical engineering biochemical engineering biological systems engineering biology biochemistry chemistry or related life science or engineering discipline with five (5) years in the pharmaceutical industry or highly regulated industry. OR

• Masters degree in chemical engineering biochemical engineering biological systems engineering biology biochemistry chemistry or related life science or engineering discipline with three (3) years in the pharmaceutical industry or highly regulated industry

Required Experience and Skills:

• Minimum two years in aseptic manufacturing or other clean room environment

• Minimum one year in people management or equivalent direct leadership experience.

• Strong contemporary knowledge of relevant current good manufacturing practices (cGMPs) regulations and current industry trends.

• Effective decision making problem solving and communication. Ability to manage multiple priorities.

• Demonstrated ability to work in fast-paced complex environments and escalate appropriately.

• Schedule: Initial training will begin on Day Shift before transitioning to Third (3rd) Shift

Preferred Experience and Skills:

• GMP quality experience with media biological drug substance and drug product.

• Strong Background in cGMP document review and approval.

• Strong background in cGMP compliance standards (QMS EHS and Site SOPs)

• Independent self-directed strong skill sets in planning / scheduling and time management.

• Experience with Quality Risk Management.

• Experience with Deviation Management.

• Experience with Kneat Veeva Vault MEDS SAP Electronic Batch Records (MES) Trackwise and GLIMS.

• RCA (Root Cause Analysis) with problem-solving experience utilizing MPS / LSS tools including demonstrated proficiency in MPS 8-Step Problem Solving.

• Software Proficiency: Microsoft Excel Work PowerPoint Teams.

Required Skills:

Preferred Skills:

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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 Monday - 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 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.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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.

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