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Merck · 2 hours ago

Executive Director, Site Quality Lead

Wilmington, DE

Full-time

Onsite

Director/Executive

$206K/yr - $325K/yr

15+ years exp

Merck is committed to using leading-edge science to improve lives, and they are seeking an Executive Director, Site Quality Lead for their Wilmington Biotech site. This role is pivotal in overseeing Quality Assurance and Quality Compliance to ensure high-quality products and compliance with regulatory standards in the manufacturing of biologics-based medicines.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

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

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

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

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

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

Qualification

Quality Management Systems (QMS)Quality AssuranceRegulatory ComplianceBiotechnologyQuality Risk ManagementGMP ComplianceEquipment ValidationSterile Filling ProcessesLean Six SigmaAnalytical SkillsLeadershipCommunication SkillsNegotiation SkillsProblem-Solving SkillsProject Management

Required

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

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

Preferred

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