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

Under general direction of the Director, Quality Control, the Associate Director is accountable for directing a team of managers and individual contributors who are accountable to provide support functions to the laboratory operations. The support includes, but not limited to, quality assurance operation/compliance for the laboratory, equipment qualification/calibration, test method qualification, test method transfer activities, change control, Laboratory automation including Information Management (LIMS), Trackwise and SAP. The individual will also manage the Stability Program.

The QC Associate Director will drive continuous improvement and supports sustainability of implemented changes identified through lean tools or from other efforts. Accountable to implement productivity enhancements to streamline activities to meet or exceed customer expectations.

Responsibilities

* Leading the activities that includes laboratory quality assurance operation, compliance, data integrity, equipment qualification/PM program, change control, QRA, laboratory automation including LIMS, planning and stability program.

* Manages a staff that edits, writes, and/or approves departmental procedures.

* Ensure cGMP and GDP compliance.

* Acts as a key regulatory compliance liaison to interface with regulatory agencies during audits of assigned areas.

* Performing duties and responsibilities of the Director in his/her absence

* Administrative and personnel actions such as hiring, transfers, training, salary and appraisal administration

* Participates in the generation and interpretation of divisional policies/guidelines

* Supports initiatives that involve the necessary human and capital resources needed to meet present and future quality control needs and managing those resources to meet annual profit plan

* Supports the achievement of plant objectives (e.g., metrics, productivity, etc.)

* Aligning resources with business unit needs.

* Manages all quality aspects of deviation, OOS/OOT etc.

Education Requirements

* B.S./B.A. degree in Science (preferable Chemistry, Biology or Microbiology)

Experience and Skills

Required

* Minimum of ten (10) years of experience in a cGMP pharmaceutical laboratory, including at least five (5) years of direct people management experience

* Experience in Quality Control Laboratory

* Provide technical direction and training to include Good Manufacturing Practice, safety practices, and good documentation practices as they relate to the quality assurance of the product

* General leadership skills to manage large teams, champion of diversity and inclusion

* Prior expert level experience in LC (HPLC, UHPLC), GC, empower, method validation/transfer, titration, dissolution, content uniformity, data integrity requirements, OOS/OOT investigations and stability programs

Preferred

* Working knowledge of SAP and Company Production System (CPS) principles

* Working knowledgeable in the use of GLIMS

* Excellent technical writing skills, presentation skills, root cause analysis, technical troubleshooting

* Audit scenarios-internal and regulatory audits

* Managing stability programs

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network thats 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., Kenilworth, 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

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

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.

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

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 anothers 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., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

10%

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R108329