Sr. Director Global Quality Management Systems - Boston, United States - Evotec WD

Evotec WD Boston, United States

3 weeks ago

Description

Sr. Director Global Quality Management Systems page is loaded

Sr. Director Global Quality Management Systems

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locations

Boston, MA

Field Based US - East Coast

Field Based US - West Coast

Cambridge, MA

Seattle

time type

Full time

posted on

Posted 3 Days Ago

job requisition id

JOB ID-10802

Just-Evotec Biologics (JEB)

is seeking a highly motivated

Sr. Director Global QMS

that desires a significant opportunity to improve worldwide access to biotherapeutics. Remote with travel.
The

Sr. Director Global Quality Management Systems (GQMS)

reports to the Global Head Quality Systems.

The primary focus of this role is to build and manage a Global Quality Management System (GQMS) that complies with US and EU regulations, laws and guidance's.

Partner with JEB leaders to shape and mature the quality systems and processes to meet various phases of development.
Responsibilities

Establish and maintain a risk-based, fit-for-purpose Global Quality Management System (GQMS) for JEB. Develop, communicate, and ensure implementation of the Quality Manual, Quality policy, standards, global procedures and processes across the JEB.
Responsible for establishing and maintaining globally the following elements of the

GQMS:
Document Control and Records Management
Data Governance and Data Integrity
Nonconformance and CAPA
Change Control
Quality Risk Management
Data Management including Quality Management Review

Responsible for the global electronic quality management (eQMS) for JEB.
Interact internally and externally with quality and site management to report on the performance of the quality system.
Establishing department / individual goals and key performance indicators in alignment with company and operational goals; maintain and report applicable department and delivery metrics
Develop and lead the Quality Management Review process, ensuring all sites report performance and system health.
Perform as a Subject Matter Expert in audits and inspections.
Coaching, training, and supporting development of the Quality Systems team.
Ensure adherence to the budget.

Driving continuous improvement and Operational Excellence culture through self-detecting and self-correcting processes and systems, and instilling strong ownership and accountability.

Qualifications

B.S. Degree in business or a scientific/technical field required. Advanced degree such as MBA or master's desired.

Minimum of 15 years' experience in multinational pharma/biopharma organizations, covering Broad knowledge and experience with quality assurance and quality system, quality operations, regulatory compliance and understanding of current international regulatory requirements and trends for the manufacturing of API, DS and DP and advance therapies.

Ability to solve organizational problems across sites to ensure standardized application of quality system practices.
Demonstrated leadership across functions and organizational levels.
Experience in strategy development and deployment, organizational change, and business improvement.
Strong people leader to engage and motivate a team of professionals.
Demonstrate the ability to incorporate sound risk management fundamentals in the establishment of the GQMS.
Demonstrates excellent interpersonal verbal and written communication.
Ability to deal with complexity, ambiguity, and multiple priorities simultaneously.
Travel to JEB local and international sites as required.
The base pay range for this position at commencement of employment is expected to be

$127,050 - $235,950 ; Base salary offered may vary depending on individual's skills, experience, and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness, and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.

About Us

Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients.

The Company's multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products.

Evotec leverages this "Data-driven R&D Autobahn to Cures" for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders.

Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases.

Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development.

Evotec operates globally with more than 5,000 highly qualified people. The Company's 17 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to

and follow us on X/Twitter @Evotec

and LinkedIn .
Please click on the link below to access and review our Privacy Information for Applicants:

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