Job Description

Job Description:

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 interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Reporting to the Director of Quality Systems and Compliance, the Associate Director - Quality Systems position will provide leadership, focus and governance to the Durham Site in the following Quality Systems: Change Management, Quality Management System (QMS), and Documentation Management. The incumbent will lead a team responsible for instituting consistent practices across the facility across these disciplines. The successful candidate will build and/or improve these site-wide management programs by defining requirements established via in-depth review of existing systems and aligned with strategic direction defined by the global business model and regulatory agencies. The role will require working with Operations, Technology, Supply Chain, and Quality on both the global and local levels. As a sub-system owner of these systems for the site, the incumbent will also be responsible for the development of metrics, ensuring consistency across the site, and presenting the system during audits and inspections.

Primary Responsibilities

• Applies management skills to align staff activities with department objectives.
• Provide management and leadership for following Quality Systems: Change Management, Quality Management System (QMS), and Documentation Management.
• Ensure compliance with all global and regulatory standards.
• Serve as the Subject Matter Expert (SME) for areas of responsibility.
• Develop and report to senior leadership data analysis and metrics to ensure systems' compliance and performance.
• Serve as a sub-system owner for the Durham site for the Change Management and Quality Management System.
• Provide guidance to staff for the implementation, management, and enhancement of document control systems on the global and local level and ensure consistent document management processes across all control documents.
• Coordinate responsibilities between site/functional management, site/functional SMEs and the Global Center of Excellence teams or Community of Practices (COPs).
• Responsible for collection and presentation of compliance (metrics), obstacles and challenges to site management, including a review of topics of responsibility at the Site Quality Council Meeting per the QC standard.
• Direct support of regulatory inspections and audits; presents Change Management, Quality Management System (QMS), and Documentation Management during inspections and audits.

Functional Expertise

• Working knowledge of Veeva Vault, SAP, Word, Excel, and Power Point; good understanding of database concepts, theory, and architecture.
• Understanding and ability to perform metrics; working knowledge of and/or experience with Change Management and GMP Documentation Management is required.
• Electronic document control systems experience is highly desirable.
• Understanding of the FDA regulations and cGMPs with experience in document control and quality management in a highly regulated industry; experience in a high-volume, mission critical environment, and excellent communication skills.

Problem Solving

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

Impact

• Influence: Explains difficult concepts and persuades others to adopt point of view and communicates information, asks questions and checks for understanding.
• Decision Making: Guided by policies and procedures - that impact the unit's ability to meet performance objectives and 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.

Strategic Planning

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

Resource Management

• Forecasts resource needs; manages allocated budget.

Education Minimum Requirements

• Bachelor's degree in science, Engineering, or related field of study

Required Experience and Skills

• Minimum five (5) years of experience within in the pharmaceutical industry in Quality, Technical, Manufacturing Operations, or related Business Operations working with Quality Management Systems and Change Management.
• Experience performing review and completing change control impact assessments.
• Proven expertise of cGMPs, technical writing, data management collection, and analysis.
• Demonstrated Quality, Technical, and / or Manufacturing experience in the areas of Change Management, Quality System Management, and Documentation Management.
• Ability to interpret complex business and/or technical documents, write comprehensive reports and detailed business correspondence, and the ability to present to groups across the organization as needed.
• Demonstrated knowledge of GMPs, compliance issues, inspectional trends, industry quality assurance practices, and systems.
• Demonstrated innovative mindset.
• Demonstrated cross cultural agility and resourcefulness.

Preferred Experience and Skills

• Lean Six Sigma Green Belt or higher certification.
• Significant experience in biologics, vaccines, and/or biopharmaceuticals compliance.
• Experience as Subject Matter Expert (SME) in presenting to regulatory agencies.
• Quality Auditing experience

Working Relationships

• Reports to Director, Quality Systems & Compliance
• Frequent interaction with employees from other departments
• Interacts with representatives from regulatory agencies.

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

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:R331410