CQV Regional Director - Candidate can be located on the East Coast or Midwest
Company: CTI Education Group
Posted on: February 23, 2021
CQV Regional Director - Candidate can be located on the East
Coast or Midwest - ( LS-00006Y ) Your Impact: Our People & Places
Solutions business - reinforces our drive to improve the lives of
people everywhere and epitomizes the "why" of what we do - the
tremendous positive impact and value our solutions bring to our
communities and society as a whole. From facilities delivering
life-saving therapies and ensuring clean water to enabling the
connection of people through all modes of transportation and
providing access to technology - we're integrating a multitude of
these solution elements to build the smart environments of
Start your Jacobs career with a company that inspires and empowers
you to deliver your best work so you can evolve, grow and succeed -
today and into tomorrow. *Candidate can be located on the East
Coast or Midwest*
The Commissioning, Qualification and Validation (CQV) Director will
provide CQV services to clients in the Life Sciences Industry. The
position provides an excellent opportunity to work for a Global
Engineering Firm and support clients that manufacture life changing
products. This hands-on Director role shall be responsible for
managing the development and execution of CQV documentation on a
variety of equipment, facilities, utilities, components, products,
and systems for a diverse client base of biotechnology,
pharmaceutical, medical device, gene therapy and cell therapy
- Directs the activities (i.e. commissioning, qualification,
validation, process transfer, etc.) of cross functional teams in
order to meet company and site objectives.
- Establishes credibility throughout the organization as an
effective developer of solutions to business challenges.
- Provides leadership and management to ensure that the mission
and core values of the company are put into practice.
- Spearheads the development, communication and implementation of
effective growth strategies and processes for CQV.
- Collaborates with the executive management team to develop and
implement plans for the CQV operational infrastructure of systems,
processes and personnel designed to accommodate the growth
objectives of the company.
- Motivates and leads a high-performance CQV management team;
attracts, recruits and retains required members of the team not
currently in place including SMEs, Project Managers & CQV
- Acts as a partner for the Business Development team to meet
sales, growth and market share objectives.
- Designs and implements appropriate CQV marketing strategies and
effectively utilizes social media to promote CQV growth.
- Fosters a success-oriented, accountable environment within the
- Serves as a trusted advisor & leader, represents the firm with
clients, and business partners.
- Works collaboratively with management and staff to identify new
clients and growth opportunities.
- Develops project cost estimates and proposals for validation
for large capital projects.
- Visits client sites and presents Jacobs CQV capabilities to
- Develops, monitors and reports on operating costs within
functional areas. Alerts Sr. Management of cost and labor over
runs. Makes recommendations and implements solutions to problems
related to same.
- Directly supervises the staff of the Validation department to
achieve ongoing compliance to evolving regulatory
- Manages, develops and supports CQV personnel and provides
mentoring and guidance pertaining to CQV work processes and
- Interfaces with clients to ensure that their needs are being
- Maintains knowledge of regulatory expectations, cGMPs, and
industry benchmarking to ensure thorough understanding of
compliance, risk management and efficient CQV support.
- Presents at conferences and networks throughout the industry to
promote Jacobs expertise in this field and the Life Sciences sector
as a whole.
- Manages accounting aspects of projects including bill rates,
estimates, budgets and contractual agreements.
Here's What You'll Need:
- BS/MS in Engineering, Technical or Life Science
- Minimum of 10 years of experience leading and managing line of
business or office in the Life Sciences industry.
- Minimum of 15 years of Commissioning, Qualification, Validation
and Compliance experience in the biopharmaceutical industry; Sound
technical knowledge of CQV.
- Extensive project management experience of small to large
capital projects in life sciences.
- Demonstrated effective leadership, financial management and
- Interpersonal and leadership skills necessary to communicate
clearly and effectively and coordinate and manage
qualification/validation activities with all levels of personnel
from various disciplines across the organization.
- Experience collaborating and working in large organizational or
functional business units.
- Results focused and self-motivated.
- Excellent communication and presentation skills.
- Flexible and willing to travel, domestic or international, as
- Competencies: Strategic Thinking, Business Acumen, Leadership,
Technical CQV knowledge, Results Driven, Financial Management,
Problem Solving/Analysis, Collaboration Skills, Presentation
Skills, Interpersonal Skills
- Engineering knowledge of, and experience with, manufacturing
equipment, process equipment, HVAC, utilities, instrumentation,
controls, and automation to support clients
- Proposal development experience
- Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA
- Knowledge of industry guidance on CQV and CSV:
- ISPE Baseline Guide 5 Commissioning and Qualification, edition
- ISPE GAMP V, A Risk Based Approach to Compliant GMP
- ASTM E2500 Standard Guide for Specification, Design, and
Verification of Pharmaceutical and Biopharmaceutical Manufacturing
Systems and Equipment
- ISPE Guideline: Science and Risk-based Approach for the
Delivery of Facilities, Systems, and Equipment, 2011
- ISPE Good Practice Guide: Applied Risk Management for
Commissioning and Qualification, 2011
At Jacobs, we help prepare people for new opportunities and
challenges. With positions at every level, openings in multiple
disciplines, expertise in a range of markets and offices around the
globe, we create an environment where you can learn, grow, and
thrive. From our competitive benefits program to our Health and
Safety initiative of Beyond Zero workplace injuries, we believe
that you'll find a flourishing career here at Jacobs. #AF
#LifeSciences Primary Location Job Posting : Sep 24, 2020, 2:27:33
PM Job Organization : PPS Job Type : Experienced Job Classification
: Full-Time Regular Work Locations : US NC Raleigh 333 FAYETTEVILLE
STREET SUITE 1100 Raleigh 27601 Capabilities : Life Sciences and
Biopharma 2019 Jacobs Engineering Group - All rights reserved. 1999
Bryan Street, Suite 1200, Dallas, Texas 75201 , USA -
+1.214.638.0145 - Contact us
Keywords: CTI Education Group, Raleigh , CQV Regional Director - Candidate can be located on the East Coast or Midwest, Executive , Raleigh, North Carolina
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