Associate Director, Quality Assurance
Job Description
If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.
Our Quality Assurance group ensures all materials inside our products and the products themselves are manufactured, tested, and distributed in alignment with our high standards of quality. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers, we create an interlinking global manufacturing network dedicated to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Our Company will construct a new manufacturing facility to significantly expand its production capacity for an oncology treatment of certain forms of bladder cancer. 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 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 Capital Project Associate Director will support this expansion. Project activities requiring support include process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of commercial product with a specific focus on release, regulatory interaction, and Quality Management system integration.
Responsibilities
Reporting to the Quality Assurance Organization, will independently manage project assignments and team
Lead a Quality team to provide end-to-end QA support for release, regulatory interaction, and Quality Management system integration. Example project focus includes:
Development of electronic batch reporting and review process
Development of release procedures and protocols
Support of regulatory interaction and preparedness to reduce project risk
Lead Quality Management system integration with existing Durham site
Lead, facilitate and participate on cross-functional teams to collaboratively address issues and achieve project milestones
Actively sponsor and develop a culture that defines a High-Performing Organization including proactively providing developmental support, coaching and assistance to team members
Ensure all aspects of the project proceed in compliance with cGMP, regulations, and our Company’s Quality Management System
During peak project workloads, provide QA support including critical / constructive review and approval of GMP documentation such as Quality Agreements, Quality Risk Assessments, URS, FAT, IQ, OQ and other technical documents to meet schedule milestones
Review and approval of master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, technical reports
Partner with site and above site functions to solve problems and achieve goals
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
Education
Bachelor's degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline
Required
Bachelor's degree, with at least ten years in the pharmaceutical industry or highly regulated industry
Master's degree, with at least eight years in the pharmaceutical industry or highly regulated industry
Minimum three years in an aseptic manufacturing or other clean room environment
Minimum one year in people or capital project management
Strong contemporary knowledge of relevant current good manufacturing practices (cGMPs), regulations and current industry trends
Effective decision making, problem solving and communication skills | Ability to manage multiple priorities
Demonstrated ability to work in fast-paced, complex environments and escalate appropriately
Preferred
Operational leadership
Biologics or vaccine drug substance and/or drug product processing
Equipment Qualification | Quality Risk Management
Project Management in a highly regulated industry
Electronic validation | Electronic batch records | SAP, Trackwise and/or GLIMS
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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.
Residents of Colorado
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US and Puerto Rico Residents Only:
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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:
Domestic
VISA Sponsorship:
Travel Requirements:
10%
Flexible Work Arrangements:
Work Week
Shift:
1st - Day
Valid Driving License:
Yes
Hazardous Material(s):
Number of Openings:
1
Requisition ID:R144848