Sr. Director/Director, Quality Management Systems
Company: Just - Evotec Biologics
Location: Redmond
Posted on: May 12, 2022
Job Description:
Just-Evotec Biologics is seeking a highly motivated Sr.
Director/Director, Quality Management System, that desires a
significant opportunity to improve worldwide access to
biotherapeutics. In this global role, the primary focus of this job
is to build QMS to support a flexible clinical and commercial
biotherapeutic operations at Just-Evotec Biologics state of the art
J.POD manufacturing network.The position is part of the Just-Evotec
Biologics Quality Leadership team and will report directly to SVP,
Quality. In this role, the successful candidate will lead a team of
QA specialists and managers and:
- Develop, implement, and enable continuous improvement of the
Quality Systems, which encompass but not limited to: QMS
(Deviation, Change Control, CAPA), Documentation, Training,
Supplier Management, Internal/Customer Audits and Customer
Complaints.
- Ensure that Quality Systems are designed and operating in a way
to provide appropriate support in all GxP areas of the company and
are in compliance with current ICH and GMP standards (cGMP) both US
FDA and EU.
- Develops, implements, and maintains corporate policy and
procedures for the Quality Management System in accordance with ICH
Q10 model
- Takes lead role in evaluating continuous improvement options
for the Quality Systems post initial implementation
- Develops user requirements and contributes to the
configuration, validation, implementation and lifecycle management
of the electronic Quality Management System (eQMS)
- Establish department / individual goals and key performance
indicators in alignment with company and operational goals;
maintain and report applicable department and delivery
metrics.
- Management of the site monthly Quality Management Review
meeting. Facilitate creation of the presentation materials to
include the Key Performance indicators, the meeting agenda and
attendance, and to orchestrate the material presentation.
- Manage internal quality improvement initiatives: evaluate
internal processes, suggest/design/implement improvements,
create/revise relevant SOPs/Policies
- Acts as subject matter expert and provides training on all
Quality Management Systems, including but not limited to change
control, quality events, investigation and implementation of
effective CAPAs
- Own and oversee the compilation of the Site Master File
(SMF)
- Supports other members of the Quality Team and organization
during its growth period in aspects not related to the core
responsibilities of the Quality Systems area.
- Responsible for the coaching, training, and development of the
Quality Systems team.
- Develop budget for department and ensures adherence to the
budget.
- Drive continuous improvement and Operational Excellence culture
through self-detecting and self-correcting processes and systems
and instilling strong ownership and accountability.Educational
Requirements:
- BS, MS. in Biochemistry, Biology, Microbiology, Chemistry or a
Scientific/Engineering degree
- 15+ years of in biotechnology or biopharmaceutical experience
in a commercial manufacturing environment.Qualification
Requirements:
- Experience in QMS, QA and Manufacturing and/QC, experience
dealing with Regulatory compliance. Experience in problem solving,
process improvement, negotiations and supervision
- Strong management and leadership skills, including
establishment of clear expectations and development of metrics and
KPIs to monitor performance and ongoing activities
- Ability to deal with complexity, ambiguity, and multiple
priorities simultaneously.
- Extensive experience and proven track record of success in
installing and managing QMS
- In depth knowledge of 21 CFR 210, 21 CFR 211, ICH Q7, ICH Q9,
ICH Q10, Eudralex - Volume 4, and Data Integrity and Compliance
with cGMP and GAMP
- Deep understanding of biologics analytical GMP testing of
clinical and commercial drug substance biological products, GMP raw
materials inspection and release, and facility environmental
monitoring programs
- Experienced in the use of electronic systems such as eQMS,
LIMS, MES/EBR, and ERP systems
- Candidate must possess strong focus on attention to detail
- Possess effective task/time management organizational
skills
- Good interpersonal, team, and communication skills are a
must
- Ability to communicate effectively over teleconference and
web-based meetings are necessary.
- Strong computer skills include Microsoft Office (Word, Excel,
Power Point, and MS Project)Additional Preferred Qualifications:
- Entrepreneurial drive to achieve business objectives
- Knowledge and expertise to solve complex technical
problems
- Active participation/lead technical projects with collaborators
and vendorsMiddle Management
Keywords: Just - Evotec Biologics, Redmond , Sr. Director/Director, Quality Management Systems, Executive , Redmond, Washington
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