Associate Director, Laboratory Operations Quality Assurance

Job Description

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

We are seeking a Growth and Improvement minded Laboratory Operations Quality Assurance Associate Director that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Strategic Summary

The Laboratory Operations Quality Assurance Associate Director within the Quality Assurance Center of Excellence is accountable for providing Quality direction and oversight to West Point Laboratory Operations in the management of those areas assigned, such as Internal Auditing, Training, Change Control, Inspection Management, Deviation Management and Risk Management, in order to maintain compliance with Regulatory requirements. The individual is an Advocate for the development, execution and deployment of the West Point Site and our Manufacturing Division priorities and drives quality improvement activities and ensures alignment across Laboratory Operations in the execution of their assigned areas. The successful candidate is responsible for the development and maintenance of Quality Systems in Laboratory Operations in accordance with cGMPs, GLPs, international regulations and our Company guidelines, policies and procedures.

The Associate Director will guide a team of individuals and support the development of personnel through effective coaching and feedback and by modeling inclusive behaviors and will lead key compliance projects for Laboratory Operations aimed at elevating the compliance posture. As a Project Manager, the individual is expected to fully manage all aspects of assigned projects, such as quality decision making, stakeholder management, issue identification and resolution, and driving all aspects of the project in alignment with established timelines.

Key Responsibilities

• Maintains strong quality management systems to actively ensure compliance while striving to optimize Quality Operations with the Laboratory

• Actively participates in the Tier process, as appropriate, and uses this forum to escalate concerns and best practices

• Serves as an Ad Hoc member of the West Point Site Quality Council

• Responsible for the Quality oversight and classification/approval of investigative events in Laboratory Operations

• Provides guidance to Senior Quality Specialists conducting reviews/approvals of investigative events

• Establishes the effects on test result validity, for laboratory investigative events, to ensure final reportable values are representative of the product’s quality

• Provide input on recommended CAPAs, as appropriate

• Completes review and approval for CAPAs, QCTS commitments, change requests, and investigative protocols and final reports

• Initiates and completes review and approval of IQ/OQ/PQ documents for assigned laboratories of responsibility

• Provides Quality consult to Senior Quality Specialists performing monthly internal audits of laboratory areas

• Reviews and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc.

• Provides coaching and guidance to new personnel and to Quality Specialist and Sr. Quality Specialist colleagues

• Provides support to Regulatory Agency Inspections

• Proactively partners with Laboratory Operations and Laboratory Technology personnel to ensure that all process improvements and capital projects are timely, robust and in alignment with corporate goals

Education

• Bachelor degree in Life Sciences or related scientific field, with five years minimum in Pharmaceutical Quality, Regulatory, or related experience with progressive and demonstrated Quality, OR

• Master degree in Life Sciences or related scientific field, with three years minimum in Pharmaceutical Quality, Regulatory, or related experience with progressive and demonstrated Quality

Experience | Knowledge | Skills

Required

• Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Prior people management experience

• Quality Systems knowledge

• Project Management, Change Execution Management and Team Leadership experience in a Quality or related function

• Interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment

• Self starter with capability to develop innovative solutions to opportunities

• Facilitate management skills and able to lead cross-functional project teams to deliver results

• Proven analytical aptitude, critical thinking skills, and ability to apply key concepts

• Speaks with courage and candor

• Principled written and verbal communication skills

• In-depth working knowledge and application of GMPs/GLPs

• Proven ability to manage multiple projects simultaneously

Preferred

• Risk Management tools and methodologies such as: FMEA, PHA, Risk Rank and Filtering, Risk reporting, etc.

• Fast learner and can be a change agent

• Technical understanding of Biologics, vaccines and small molecules business

• Understanding of our Company Quality System

• Direct floor manufacturing shop experience

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals 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.

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.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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):

Number of Openings:

Requisition ID:R181835