Senior Specialist, Manufacturing Product Quality

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 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 Senior Manufacturing Product Quality Specialist 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 dedicated 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 dedication 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 Senior Manufacturing Product Quality Specialist is accountable providing Quality Oversight of external parties, that manufactures biologics on behalf of our Company. Ensures that all biologic products manufactured at external partners and alliances are manufactured, packaged, analyzed, released, stored and distributed in accordance with our Company expectations and all applicable regulatory requirements.

Remain informed of current GMP requirements and industry trends. Support review of regulatory filings, requests for information and subsequent supplemental packages as required. Advise support groups on aspects of GMP compliance. Support the development of GMP policies and procedures. Ensure all SOPs are aligned with current policies and applicable regulations. Build and maintain strong relationship with external parties. This also includes providing support to build effective quality systems at the partner and supporting continuous improvement activities.

Key Responsibilities

• Participates in routine Tier 2 meetings with the external partner

• Supports the collection of QPI and KPI metrics in support of Quality Council and Calibrated Quality Oversight (CQO)

• Reviewing executed batch records for completeness and compliance to all associated regulatory filings and executing the batch disposition process

• Management of transfer under quarantine requests and internal complaints

• Defining Quality requirements on Change

• Requests submitted by the external partner and ensuring conformance to all identified requirements prior to authorizing release of batches made under the changes; will ensure all validation expectations are met, where necessary, by on-site support for demonstration batches or validation batches

• Guides investigations conducted by the external partners' into abnormal operational occurrences such as batch rejections, atypical events, customer complaints etc.

• Coordinates support from appropriate staff groups and recommends corrective measures

• Assists in the coordination of significant investigations including Fact Findings and the coordination of product recalls

• Manages the entry, coordination and completion of deviations and CAPA in COMET SAP system in accordance with timelines defined in departmental procedures

• Closely partners with appropriate business and operations areas to achieve our Company objectives

• Coordination and final assembly of the Annual Product Review package provided by the external partner

• Monitor the external partner to ensure that effective and robust Quality Systems and Quality management are in place

• Provides on-site guidance in the preparation of metrics, procedures and guidelines where warranted

• Operate in a safe and efficient manner and in compliance with our Manufacturing Division QO Safety and Health Policy

• Assure compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.), both domestic and foreign

Education

• Bachelor degree or higher in a scientific or technical discipline

Required

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

• Five years in the pharmaceutical industry with a thorough knowledge and expansive experience of Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements

• Direct experience working in COMET SAP for batch disposition, deviation management (including CAPA), PCR Trace and change control processes in GCM Trackwise

• Principled verbal and written communications

• Effective interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build good and strong foundational relationships

• Navigate in a complex environment with the ability to make ambiguous situations clear to stakeholders (e.g., process mapping, PowerPoint)

Preferred

• Experience with biologic and/or vaccine Quality Assurance, Quality Control and manufacturing processes

• Effective analytical and computer skills, including SharePoint and Spotfire

• Strong leadership, partnership, influencing skills along with Six Sigma /MPS experience

• Ability to work independently and interact with all levels of the organization

• Prior experience in Technical Transfer

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., 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.

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.

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Requisition ID:R181262