Associate Director, Quality Compliance
The Associate Director, Quality Assurance, West Point Site Compliance reports to the Site Compliance Lead in Global Development Quality. The Associate Director is responsible for ensuring continuous compliance of investigational medicinal products with cGMPs and relevant international regulations (e.g., USA, EU, etc.). The Associate Director will support the site self-inspection program, Health Authority inspections, perform general GMP readiness activities, and compliance initiatives, as necessary.
Responsibilities include, but are not limited to:
Leading and supporting self-inspections and inspection readiness activities of new and existing manufacturing facilities, laboratories and support areas within the Clinical Supply network.
Lead and support internal audits and assessments to ensure compliance with relevant regulations.
Ensure compliance with applicable regulations, policies, and procedures.
Issue reports summarizing findings and tracks resulting CAPAs to satisfactory closure to maintain appropriate risk posture for the site. Notifies relevant management of unresolved issues or trends.
Develop and maintain metrics and key performance indicators to measure trends and improve quality performance. Perform trending reviews of observations and commitments, compile trend reports and present outcomes to management and governing Quality Councils.
Maintain an expert level of knowledge about GMP requirements and industry trends as described in applicable worldwide regulations. Will provide guidance and interpretation of GMP, regulatory, and compliance standards.
Lead and support the preparation activities for EU GMP Compliance audits and Health Authority Inspections as needed.
Track audit and inspection commitments to closure.
Develop and harmonize procedures and processes that promote, facilitate and ensure compliance with domestic and international regulations and industry standards in support of the company’s objectives.
Proactively identify, develop and implement opportunities for work/process improvement and efficiency
Promote a culture of quality and operational excellence. Proactively identify areas for improvement and work across multiple organizations to influence and implement solutions.
Represents Development Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing Quality guidance.
Bachelor's Degree in appropriate Science (chemistry, biology, biochemistry, microbiology), IT or Engineering discipline.
Advanced degree preferred.
The Candidate should have:
Minimum 10 years of experience in Quality Assurance/Compliance in the pharmaceutical, biopharma/biologics or related industry performing direct hands-on work in Quality Assurance, Quality Control, laboratories, manufacturing, supply chain, facilities or engineering.
Extensive knowledge of Good Manufacturing Practices (GMPs), US FDA and EU GMP regulations and ICH guidelines.
Demonstrated knowledge and direct experience with developing and establishing Quality Systems and GxP compliance within a regulated environment.
Experience leading internal and external audits.
Background in hosting and/or supporting US and EU health authority inspections.
Strong leadership skills to lead cross-functional teams.
Extensive experience using electronic quality systems to monitor, report and track quality tasks and key performance indicators.
Excellent attention to detail.
Proficient in PowerPoint, Excel, and Word.
Demonstrated experience using Quality Risk Management tools.
Excellent verbal and written communication and presentation skills across all levels.
Prioritize and manage multiple priorities and projects independently.
Familiarity with R&D or clinical supply areas and processes.
Superior collaboration and teamwork skills.
Understanding of lean sigma principles and tools.
Sterile manufacturing experience and knowledge of US and EU aseptic processing guidelines.
Ability to apply basic scientific and regulatory principles utilized to solve routine operational, and quality tasks.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Rahway, 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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For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
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Residents of Colorado:
Click here to request this role’s pay range.
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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.
Flexible Work Arrangements:Hybrid
Shift:1st - Day
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