POSITION RESPONSIBILITIES

With energy and enthusiasm, the Drug Substance Quality Lead will: a) Acting in the role of leading the Drug Substance (DS) Quality Assurance team. b) Responsible for ensuring that the processes for the manufacture of biologics DS have been conducted in compliance with GMP, the registered marketing authorisation and the associated regulatory requirements. c) In-depth knowledge of US and European GMP guidelines, ICH and other international regulatory requirements, as applicable to the site. d) Drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements. e) Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations. f) Assisting in, and facilitating investigations, ensuring effective Root Cause Analysis and CAPAs. g) Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site. h) Be an advocate of continuous improvement in the Quality Management Systems. i) Provide Quality oversight to the qualification/validation, technical transfers, regulatory approvals and commercial operations for DS at the facility. j) Responsible for the management of batch record review, discrepancy reporting, investigations and CAPAs associated with Drug Substance Release. k) Drives opportunities for continuous improvement. l) Provide audit support and participate in response team for audits and inspections by Health Authorities. m) Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions. n) Manage team of shift specialists within the Drug Substance QA Operations organization.

REPORTING STRUCTURE

This position will report into the Director-QA Operations for the site.

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

General This role requires a seasoned Associate Director with a minimum of 10 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations. A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends. The successful candidate will also ideally have a proven track record in delivering excellence. Direct experience in manufacture of antibody drug conjugates preferred. The candidate will also show ambition and drive to develop and advance their career within our company. Technical Must have at least 5 years of operational experience in a regulated environment. Must have experience in supporting tech transfer or process validation either internally or externally. Must have experience in drug substance quality operations and batch record review. Demonstrated knowledge of Cleaning in Place, Cleaning out of Place, Sanitize in Place. Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc). Exceptional analytical, problem solving & root-cause analysis skills. Ability to multi-task and handle tasks with competing priorities effectively. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & experience interfacing with regulators is preferred. Strong operations support background ensuring value added and effective quality oversight. People A great communicator with proven ability to deliver excellence Knowledge of relevant cGMPs, regulations and current industry trends related to Antibody Drug Conjugate drug substance Manufacturing. Experience with new product introductions and/or process qualification/technology transfer Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc. Excellent communication skills (written and oral). Required to work on his/her own initiative in addition to working as part of and guiding a team. Must be able to work across a team matrix to meet accelerated timelines. Desire to continuously learn, improve and develop. Ability to facilitate groups with diverse perspectives and bring teams to consensus and alignment. Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner. Able to demonstrate good judgment in collecting and synthesizing relevant data and information to enable timely decisions; communicates and escalates issues and decisions as needed. Planning and scheduling skills, Proven organizational skills, Flexible approach. Goal/results orientated, Starter/Finisher. Education Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or in a relevant discipline.

Required Skills:

Adaptability, Adaptability, Antibody Drug Conjugates (ADC), Batch Releases, CAPA Management, Change Management, Continuous Improvement, Cross-Cultural Awareness, Cross-Functional Teamwork, Design Controls, Deviation Management, GMP Compliance, GMP Training, Inspection Readiness, Manufacturing Quality Control, Multitasking, People Management, Preventive Action, Quality Assurance Processes, Quality Auditing, Quality Control Management, Quality Management, Quality Management Standards, Quality Metrics, Quality Systems Compliance {+ 2 more}

Preferred Skills:

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. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights

EEOC GINA

Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

Regular Relocation:

Domestic VISA Sponsorship:

No Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable Shift:

1st -

Day Valid Driving License:

No Hazardous Material(s):

Yes Job Posting End Date:

A job posting is effective until 11:59:59PM on the day BEFORE the 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:

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