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.

GENERAL SUMMARY:

The Manager, Teknika QC laboratory, is responsible for managing a team of individual contributors responsible for the environmental monitoring and routine release testing of BCG at the Teknika site in Durham, North Carolina. Additional duties will include support of site business processes, such as change control, deviation management, audits and regulatory inspections. The Manager will be responsible for using principles of our Company Production Systems, Lean Laboratories, and cGMP requirements in the laboratory. The Manager will manage the team and coordinate the execution of routine testing of product, continuing process improvements, troubleshooting, writing SOPs, and investigational testing support.

GENERAL PROFILE:

• Management of laboratory personnel responsible for analytical assays

• Collaborate with internal customers and vendors to identify, evaluate and implement process improvements that expand site capabilities

• Apply project management concepts and techniques as they relate to analytical testing, regulatory requirements for new assay development/validation, project timelines and budgeting

• Provides technical guidance to employees and colleagues

• Understand and apply cGMP/Good Laboratory Practice, Compendial, and other applicable regulatory requirements toward analytical testing

• Provides leadership daily to ensure routine analytical testing is performed within established delivery timelines without errors

• Ensure laboratory safety including chemical handling and biosafety level regulations

• Maintaining labs in an inspection-ready, cGMP-compliant state and represent the laboratory during audits and inspections (regulatory, internal, safety)

• Build and maintain strong relationships with site leadership, stakeholders, and customers

• Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals

BUSINESS EXPERTISE:

• Applies management skills to align staff activities with program and department objectives

FUNCTIONAL EXPERTISE:

Manager will be responsible for comprehensive management of all activities required to successfully support the QC laboratory Team to include the following:

• Quality Manager overseeing analytical testing and personnel

• Lead the team and others by providing direction and guidance

• Knowledge of microbiological, analytical and maintenance procedures

• Knowledge of assay development and routine testing

• Author/review technical documents, standard operating procedures, change controls, and investigations for the performance of laboratory methods

• Trouble-shoot analytical process and equipment issues as needed

• Planning and test method execution to meet established delivery timelines

• Provide active support during audits and inspections (regulatory, internal, safety)

• Collaborate with site compliance team to ensure adherence to regulatory requirements

• Review and approve Quality Notifications

• Train employees on new or revised processes or procedures

• Determine staffing needs and hire to meet those demands

• Participate in Kaizen events

Other:

• Direct support of regulatory inspections and audits

• Direct support of validation activities and all other associated Quality functions.

• Other duties as requested by Management including functioning as delegate

PROBLEM SOLVING:

• Identifies and resolves standard day-to-day technical and operational problems within own area of responsibility.

IMPACT:

Influence

• Represents Quality in the laboratory to influence cGMP compliance and ensure product quality.

• Explains difficult issues and obtains agreement as needed.

Accountability

• Accountable for the performance of work group and delivery of analytical results.

• Accountable to other stakeholders supporting analytical assay development and qualification.

• Accountable to stakeholders requiring assay performance and product testing.

Decision Making

• Makes decisions - guided by policies and procedures - that impact the labs ability to meet performance objectives.

• Consistently consults with next-level manager on non-standard decisions and/or issues that impact other units with interrelated processes.

• Makes decisions within guidelines and policies that impact own priorities and allocation of time to meet deadlines.

• Escalates potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality

STRATEGIC PLANNING:

• Sets priorities for laboratory/analytics to meet daily deadlines; develops plans to meet short-term objectives.

RESOURCE MANAGEMENT:

• Works within budgetary/ financial objectives set by management.

Education Minimum Requirements:

• Bachelor's Degree in Biology, Biochemistry, Chemistry or other relevant discipline

• Minimum 5 years of experience in pharmaceutical laboratory operations

Preferred Experience and Skills:

• Quality Control, Quality Assurance and/or cGMP experience

• Minimum of 1 year managerial or team lead experience recommended

WORKING RELATIONSHIPS:

• Reports to Quality Control Associate Director

• Manages and interacts with employees within own department

• Frequent interaction with employees from other departments

• Interacts with representatives from regulatory agencies

Note:This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

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Current Employees apply HERE

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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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R330010