Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Quality Operations (QO) Manager, with guidance from the IPT Quality Operations Leader, supervises the activities of their quality team members. They are responsible for ensuring adherence to Divisional, Company and Site policy, procedures and guidelines. They ensure product/process quality through the review of GMP documents, facilities and processes and perform activities to ensure the reliable release of quality products to the marketplace.
The QO Manager position requires strong quality/analytical/scientific skills, as well as leadership abilities in order to manage Quality Operations within their team. Strong collaboration, communication, decision making and talent management skills are QO Manager attributes. Key elements of this position are detailed process and facility knowledge, frequent shop floor presence and strong emphasis on personnel development.
Qualifications: Education Minimum Requirement:
- Supervise the activities of Quality Staff. A core responsibility includes coaching and teaching their teams and administering all personnel policies and development programs. Ensure QO personnel operate safely and committed to safety excellence and engagement with IPT. Ensure compliance to established policies/procedures of the Division and Corporation and to all applicable governmental regulations (GMP, EPA, etc.), both domestic and foreign. Driving inclusion and engagement in the IPT is a key aspect of their leadership.
- Acts as the primary QO contact for their area of support. As such, they must have sound knowledge of a wide variety of process, analytical, chemical, microbiological, instrument and automation disciplines associated with operations. They are accountable for the shared operations, quality and technology objectives for their area within the IPT, including deviation and discard reduction, schedule adherence, cycle time reductions and right first time. Coordinates and executes all Quality Operations activities to ensure production plans are met, utilizing the tier process. Supports project work in the building.
- Manages aspects of the material control and/or release process as it relates to control of material for deviations and risk processing.
- Performs review and approval for investigations, CAPAs, QCTS commitments, change requests, risks, IQ/OQ/PQ, Master Batch Records (MBRs), LIMS CRs, ACRs, etc.
- Perform GMP walkthrough inspections to ensure compliance with cGMPs and regulatory requirements.
- Actively participates in site inspections/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information and presenting to inspectors on required topics as Quality representative for the IPT. Supports the preparation of regulatory filings.
- Write, review, approve SOPs and other instructional documents for shop floor.
- Expected to have presence on Shop Floor, and incorporate Quality On the Floor into their team objectives.
- Provides training to incoming personnel and ensures compliance with departmental procedures.
Required Experience and Skills:
- Bachelor's degree. Technical emphasis in a scientific or engineering field preferred; candidates with majors in other fields will be considered if accompanied by relevant experience.
Preferred Experience and Skills:
- Experience: Minimum of 5 years of experience in Quality Operations, Quality Control (Laboratory Operations or Environmental Monitoring), Quality Assurance, Manufacturing Operations, or related field.
- Skills: Strong understanding of regulatory requirements (domestic and international)
- Aseptic/Sterile processing experience preferred.
- Experience in a supervisory/management capacity preferred.
- Demonstrated leadership expertise working with cross-functional teams on complex projects
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org. Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC GINA Supplement