Quality Compliance Regulatory Associate Director
Company: CAI
Location: San Francisco
Posted on: January 27, 2023
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Job Description:
Quality Compliance Regulatory Associate Director Business Areas
- Quality, Compliance, & Regulatory / As an Associate Director for
the Quality and Compliance Business Area at CAI, you are a leader
and subject matter expert who is responsible for establishing,
growing, and leading Quality and Compliance. The position will
engage in marketing, direct sales or sales support to regions and
facilitate in the development and implementation of systems and
initiatives to grow the business for long term success. The
candidate will work for and report to the Quality, Compliance and
Regulatory Affairs (QCR) business area leader (BAL). 1. Is engaged
in industry forums, speaking, writing articles, participating in
society committees, supporting standards or guidance document
creation within such groups, and has a network of industry contacts
who would recognize you as being an expert in Quality and
Compliance. 2. Create and contribute to content in industry
changing approaches that will benefit CAI web site and marketing
materials. 3. Can provide consulting to clients in the areas of
Quality and Compliance. 4. Provide significant support to the BAL
with respect to quality systems, knowledge management, services
definition, and delivery in the DL's area of expertise. 5. Can act
in a Quality and Compliance role including managing client
relationships for a portfolio of products and be responsible for
close liaison with the management/ other key personnel in line with
time frames per the project schedule. 6. -Engages in strategic
project work designed to be a door-opener for larger teams once the
initial expert engagement is over, or as part of a larger project
to deliver special expertise. 7. -Be responsible for the management
of one or more Quality and Compliance life science projects,
support the client in understanding the regulated environment by
serving as an advisor on the cGMP guidelines and on industry
practices and norms. 8. Builds and maintains strong relationships
with the regulatory authorities and other stakeholders as
appropriate to ensure ease of access and influence. 9. As a leader,
work collaboratively with CAI agents to sell QCR services and
provide strategic project work. 10. Develop and grow others in
developing our existing agents through execution of compelling
development plans, special initiatives and/ or collateral duties .
Requirements include: Position Requirements: Work on sites as
needed - will be hybrid, not 100% remote Minimum BSc., with
Biological / Biotechnology degree an advantage. Postgraduate
qualification an advantage. Minimum 10 year's experience in a QA or
equivalent role. Extensive experience in cGMP systems,
pharmaceutical manufacturing and testing, experience must include
role(s) in a manufacturing setting. Sterile manufacturing and/or
biotech experience distinct advantage Managerial or Supervisory
experience required. Regulatory inspection experience leading a
function or group experience preferred. Quality Control Laboratory
experience Preferred experience including, but not limited to the
following: o Application of cGMP to manufacturing and quality
systems. o Batch release and investigations o Change Management and
CAPA o Regulatory Affairs o Validation and Qualification o
Technical Transfers o Electronic and paper Quality Management
Systems Ability to coach individuals and lead teams. Self-motivated
and self-managing. Excellent oral and written communication skills
Able to identify, execute and prioritize work tasks/projects with
an awareness of escalation responsibility as needed. Critical
problem-solving skills Organizational and operational agility, able
to operate at all levels of the organization and able to shift
priorities successfully. An understanding of the pharmaceutical
industry and its unique business responsibilities Excellent
facilitation and presentation skills Ability to plan, organize and
prioritize. Excellent technical and compliance based writing
skills. Ability to work with clients of a diverse incumbent skill
base. Ability to manage projects involving multiple functional
groups. Requires negotiation skills to effectively influence
others. Other Requirements: Excellent oral and written
communication skills in English/Fluent in English Able to travel
domestically and internationally as required - Able to work (paid)
overtime - Able to work in the US without sponsorship now or any
time in the future Must have been vaccinated or willing to be
vaccinated for COVID-19 prior to starting employment - About CAI
CAI is a 100% employee-owned company established in 1996 that has
grown to more than 800 people worldwide. We provide commissioning,
qualification, validation, start-up, project management and other
consulting services associated with operational readiness to FDA
regulated and other mission-critical industries. Meeting a Higher
Standard Our approach is simple; we put the client's interests
first, we do not stop until it is right, and we will do whatever it
takes to get there. As owners of CAI, we are committed to living
our Foundational Principles, both professionally and personally: We
act with integrity. We serve each other. We serve society. We work
for our future. With employee ownership, one person's success is
everyone's success; we work diligently to accomplish team goals. We
place Team Before Self, demonstrate Respect for Others, and possess
a Can-Do Attitude (our core values). That is how we have grown
exponentially. Our full-time positions offer competitive
compensation and benefits which include: up to 15% retirement
contribution, 24 days PTO and 5 sick days per year, health
insurance at extremely low cost to employee, financial support for
both internal and external professional education as well as 70%
long term disability paid for by the company. #LI-JP1 We are an
equal opportunity employer; we are proud to employ veterans and
promote diversity and inclusion in our workplace. Diversity is a
strength for our global company. -We pledge that CAI will be
operated in a way that is fair and equitable to all - our
employees, our customers, and the broader society. This job
description is not all inclusive and you may be asked to do other
duties. CAI will also consider for employment qualified applicants
with criminal histories in a manner consistent with the
requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance
(FCO). -
Keywords: CAI, San Francisco , Quality Compliance Regulatory Associate Director, Executive , San Francisco, California
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