Executive Director, Site Quality Lead

Job Description

At our companys 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 worlds most challenging healthcare needs.

The Wilmington Biotech site will play a pivotal role in the manufacturing of our companys biologics-based medicines including in the area of immuno-oncology. This site will establish our companys 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 companys 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 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 companys 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 QRAdocumentation

• Provide concurrence on initiation of new Quality Risk Assessments (QRAs).

• Approve quality risk control decisions (risk reduction and risk acceptance) within area ofresponsibility.

• 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 manufacturers established quality policy and objectives.

Education:

• Bachelors 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:

Preferred Skills:

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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 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

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 employees 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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