Executive Director, Site Quality Lead

Merck•Wilmington, DE

1d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in a technical discipline (e.g. Biochemistry, Chemistry, Microbiology) or equivalent. A higher degree is desirable.
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.
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
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
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
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

Nice To Haves

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

Responsibilities

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.
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.
Withhold products from distribution if needed pending resolution of quality or compliance issues.
Recommend market actions, up to and including recall of product.
Ensure a current site master file where required.
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.
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
Co-chair the site Quality Council along with the respective site Operations lead.
System Owner for the site Quality System.
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.
Ensure the timely and accurately health authority reporting as established in QMS 8.5 Health Authority Reporting global procedures.]
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.