Job Description
At our company's Wilmington Biotech site, we are committed to ‘Using the power of leading-edge science to save and improve lives around the world’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.
The Wilmington Biotech site will play a pivotal role in the manufacturing of our company's biologics-based medicines, including in the area of immuno-oncology. This site will establish our company's internal capability to manufacture high potent compounds with full manufacturing and testing operations.
This facility will be a significant supplier of antibody drug conjugates and high potent compounds and will also be critical in the future supply of new biotechnology products to its global network.
Reporting to End-to-End Operating Unit Quality Operations, and a member of the Site Leadership Team, the Site Quality Lead plays a key role in the delivery of digitized, compliant Quality systems and processes to support the development, technology transfer, manufacture, testing and disposition, stability and storage of products manufactured at the Wilmington Biotech site.
Direct responsibility for correct execution of all phases of Quality Assurance of the Wilmington Biotech site from facility design through to routine testing and production. Responsible for implementing procedures and programs so that the quality department operates effectively and in a timely and cost-effective manner to assure high quality products from the Wilmington Biotech site. Ensure that objectives are effectively achieved, and are consistent with our company's requirements to ensure compliance, safety and reliable supply to our customers.
Principal Accountabilities:
Identify, recruit and manage the Quality Leadership Team, implementing a strong quality culture and ensuring staff engagement and development in line with the site competency framework.
Demonstrate Quality leadership to the site providing guidance and interpretation on the regulatory requirements for the phase appropriate manufacture and or testing of the products at Wilmington Biotech
Lead the Quality team in demonstrating a strong culture of customer support (internal and external) setting up compliant processes that are understood, easy to follow and reduce waste. Developing and maintaining a management philosophy and accountabilities which encourage continuous improvement to reduce risk.
Member of the Capital Project Leadership Team driving the design, construction, and qualification of the new site and establishment of the critical site into our company's network.
Drive a high performing and inclusive culture, stimulating personal growth and development.
Drive the establishment and licensure of a fully digitized facility to support both commercial products as well as clinical supply.
Build relationships with internal departments, regulators, customers and external organizations to support the development and growth of the business. Encourage collaborative/supportive working within the different departments and across functional interfaces.
Prepare annual budgets (Profit Plan and Capital) for the Quality department and is responsible for budgetary control, ensuring that any deviations from approved Profit Plan and Capital Plan are agreed in advance with the Vice President, Global Biologics.
Drive continuous improvement by leading and active participation in system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.
a. The core areas of:
Quality Compliance, such as managing pre-licensure meetings and regulatory inspections, the site auditing program, customer complaints, investigations and CAPAs including factfinding and recall activities as required. Serve as the Primary point of contact for regulatory agency inspectors.
Quality Assurance including implementation and maintenance of QMS documentation systems, change management, Quality Risk Management, Quality agreements, Batch record review and disposition. Provide Quality oversight of deviation investigations, or review Annual Product Reviews/Annual Product Quality Reviews
Quality Control, testing of all samples including raw materials, intermediates, packaging components, drug products, and environmental monitoring samples.
b. Withhold products from distribution if needed pending resolution of quality or compliance issues.
c. Recommend market actions, up to and including recall of product.
d. Ensure a current site master file where required.
e. Oversight on the development, implementation, and maintenance of procedures to ensure conformance with Manufacturing Quality Standards, Global SOPs, and Local Operating Procedures and local regulatory requirements.
f. In relation to Quality Risk Management (QRM) shall:
Sponsor the QRM process and Site Quality Risk Management Committee (SQRMC)
Approve quality risk control decisions (risk reduction and risk acceptance) and QRA documentation
Provide concurrence on initiation of new Quality Risk Assessments (QRAs).
Approve quality risk control decisions (risk reduction and risk acceptance) within area of responsibility.
Provide effective oversight and management of site QRM governance, review, communication and metrics
g. Co-chair the site Quality Council along with the respective site Operations lead.
h. System Owner for the site Quality System.
i. Monitor of site performance of the quality systems and report quality performance metrics and any significant quality events/issues to End to-End Operating Unit management.
j. Ensure the timely and accurately health authority reporting as established in QMS 8.5 Health Authority Reporting global procedures.]
k. Shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the 21 CFR 820 requirements and the manufacturer's established quality policy and objectives.
Education:
Bachelor’s degree in a technical discipline (e.g. Biochemistry, Chemistry, Microbiology) or equivalent. A higher degree is desirable.
Required Experience and Skills:
Significant experience in a comparable role; would typically have experience leading a functional area and contributing to the business at a directional, strategic level; ideally in a manufacturing, preferably GMP setting.
At least 15 years’ experience in the biotechnology and/or pharmaceutical industry
Proven ability to lead a Quality Team with > 10 years’ experience in Quality.
Core Experience and Skills:
Knowledge of regulatory/code requirements to US and International Codes, Standards and Practices
Equipment and process validation
Drug substance/Conjugation processes
Sterile filling processes and equipment
Understanding of business and operations management models and their application
Recruitment and selection
Lean Six Sigma Methodology experience desired
Preferred Experience and Skills:
Experience in ADC and biologics drug product and/or drug substance experience process optimization, scale-up and technology transfer of products to pilot/commercial
Operations experience in the manufacturing of potent and sterile drug products, at pilot and/or commercial scale.
Experience with commercialization of ADC programs through PPQ and launch
Working knowledge in analytical methods and product attributes for ADCs
Business:
Excellent communication, presentation and interpersonal skills
Progressive people management skills
Negotiation skills
Demonstrable analytical and systematic problem-solving skills
Strong influencing skills
Business acumen
Proven financial management skills
Risk management skills
Strategy development
Ability to effectively manage complex projects across multiple discipline
Leadership:
Entrepreneurship
Business Savviness
Strategic Planning
Decision Making
Talent Growth
Execution Excellence
Change Catalyst
Ownership and Accountability
Innovation
Motivation and Inspiration
Emotion Intelligence
Networking and Partnerships
Coaching and Development
Diversity, Equity, and Inclusion
Influence
Required Skills:
Accountability, Accountability, Biochemistry, Biotechnology, Change Management, Confidentiality, Consumer Complaint, Corrective Action Management, Cross-Cultural Awareness, Environmental Monitoring, GMP Compliance, Key Client Relationships, Leadership, Management Process, Microbiology, Molecular Microbiology, Motivation Management, Operational Quality, Operations Management, People Leadership, Quality Control Management, Quality Management Systems (QMS), Quality Monitoring, Quality Risk Assessment, Quality Risk Management {+ 4 more}Preferred Skills:
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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:
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.
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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”.
The salary range for this role is
$206,200.00 - $324,600.00This 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
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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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RegularRelocation:
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Job Posting End Date:
11/18/2025*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.