Director, Quality Operations Integrated Process Team

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 Quality Operations Integrated Process Team 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

Reports to Executive Director, Quality Operations Integrated Process Team, interacts with employees of all levels of responsibility and authority throughout the organization, works directly with Federal Drug Administration (FDA) inspectors and other regulatory agencies to present and defend Quality data. Will work closely with vendors, contractors, suppliers and partners. Responsible for managing the quality organization overseeing the daily operations of the Operations Integrated Process Team (IPT). Ensures that the production facilities and operations carried out in those facilities, maintain a state of Good Manufacturing Practices (GMP) compliance. Responsible for the release activities associated with material produced in the IPT.

Key Responsibilities

General Profile

• Provides direction to the IPT Quality Assurance team (including Associate Directors, Managers, and individual contributors (professional employees) who provide direct support for sterile manufacturing and release of Vaccine drug product with responsibilities including batch disposition, deviation management, change control, environmental control and shop floor

• Collaborates with Operations and Technology to contribute to the performance and results of a department

• Adapts departmental plans and priorities to address resource and operational challenges

• Decisions are guided by policies, procedures and business plan | Receives guidance from Executive Director of Quality

• Provides technical guidance to employees and colleagues | Leverages risk-based decision making and encourages innovative solutions

• Anticipates and interprets client and/or customer needs to identify solutions

• Ability to work independently and as a member of a team

• Ability to invest time, as required, expediting or completing assignments or projects This shall include working non-standard hours such as evenings and weekends as necessary.

Business Expertise

• Applies management skills to align staff activities with department objectives

Functional

• Plan, initiate, implement and oversee department activities with a focus upon ensuring attainment of department objectives

• Provide performance management and career development for subordinate supervisory and/or technical staff

• Develop and implement operational, policy and procedural directives for area(s) of assigned responsibility

• Review and approve recommendations for lot disposition decisions presented by staff

• Develop and administer budgets, schedules and performance requirements for department, including accountability for results in terms of costs, methods and employees

• Develop departmental strategic staffing plans and justifications for headcount and capital equipment requests

• Participate with senior and executive management in the decision making process for capital equipment expenditures and the acquisition of new technologies

• Utilize continuous improvement to accomplish department goals in the most cost effective and productive manner while maintaining high quality standards

• Review and approve deviation investigations and change requests

• Represent department during FDA and other Regulatory Agency Inspections

• Attend team, department and corporate meetings as required

• Attend Tier meetings and other site meetings as required as designee of Site Quality Head

• Serve as Grant of Authority (GOA) for Site Quality Head

• Attend seminars and/or classes as necessary to support business demands

Problem Solving

• Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units

Impact

• Errors in work or judgement may result in GMP Compliance or Regulatory deficiencies for areas of oversight | Errors in work will result in schedule or program delays and may require allocation of additional resources to correct | Errors in work will delay projects and/or schedules in other departments

• Influence Explains difficult concepts and persuades others to adopt a point of view

• Accountability Accountable for the performance and results of own unit

• Decision Making Makes decisions guided by policies and procedures that impact the unit’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

Leadership

• Strategic Planning: Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges

• Financial/Resource Management: Forecasts resource needs; manages allocated budget

Scope

• Manufacturing Operations Accountability for the performance and operations of a small manufacturing sub-segment with Plant Transfers to Inventory less than $25M and 2) Second level manager typically with M1s as direct reports

Education

• Bachelor Degree in Engineering, Biology, Chemistry, Biochemistry or other relevant Life Science discipline.

Required

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

• Twelve years in the pharmaceutical industry

• Developed conceptual knowledge in own discipline and broadened skills

• Effective interpersonal skills including the ability to effectively collaborate with staff from other departments

• Principled written and verbal communications

• Strong presentation skills including the ability to prepare and deliver professional presentations to external business interests

Preferred

• Experience supervising staff in a Quality Control and/or cGMP environment

• Familiarity with disciplines outside of primary areas of expertise

• Experience with sterile manufacturing

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed 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., 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

Click here to request this role’s pay range.

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:R180969