Director of Quality Assurance
Our client is a growing Pharmaceutical division of a leading manufacturer of preeminent Healthcare products. The company has a broad product offering, strong branding, a stable growth history and enjoys a reputation as a leader in innovation and clinical education.
The Company is profitable, growth oriented, well resourced, fiscally
disciplined, and committed to market expansion. This is a state
of the art facility designed to bring online a new Aseptic Fill
and Sterile Packaging operation. The focus of this role is to ensure
the facilities are brought online efficiently, product transfers
and start-up processes are timely, and that products are manufactured
to the highest standards of quality compatible with the requirements
of global markets. Candidates must be comfortable reporting to
an off-site GM and maintaining the independence of QA decision
while working in harmony with the facility’s Director of
The Director of Quality Assurance and Director of Operations report to the division's General Manager.
The role has 3 direct reports.
An advanced degree in a related life science area is required and a doctorate preferred.
A highly credible individual with strong leadership, motivational, organizational, presentation and communication skills is essential for success. The ideal candidate will be an independent minded, analytical thinker, with a rational and logical decision making style capable of effectively managing both people and projects. The ability to effect change and achieve results while developing and mentoring others is critical. The role requires someone with the capacity to understand how to drive a new department while implementing processes and structure, and fostering initiative, responsibility, accountability and pride.
The Director of Quality Assurance will be responsible for:
- Defining and managing the Pharmaceutical division’s
quality system in order to ensure adherence to Good Manufacturing
Practices (cGMP) and to achieve and maintain compliance with
all applicable federal, state, local and global regulations and
standards. Establishes and maintains a culture of compliance
and commitment to achieving divisional goals.
- Directs and manages the functions and activities of
Quality Assurance, Microbiology and Analytical Departments and
their managers to ensure optimum performance. The Quality Assurance
Director will develop, implement and effectively manage the programs,
processes, metrics, and reporting mechanisms necessary to improve
productivity, increase efficiency, cut costs and to ensure projects
meet expectations and timelines.
- Reviews the Quality Program and formulates programs
and procedures to drive continuous improvement. Implements and
maintains an effective internal audit program.
- Champions quality initiatives to ensure timely product
start-up and transfers working closely with other key functions
to drive compliance, meet operational deadlines and improve
customer satisfaction with all products.
- Creates a positive results-oriented
environment and fosters good employee relations.
- Keeps abreast of currents trends and best Quality
practices and serves as a member of the senior management team
responsible for leadership of the Pharmaceutical Division.
Candidates should posses the following abilities and attributes:
- Ten years of progressively responsible experience
in managing the quality assurance, microbiology and analytical
chemistry functions in a manufacturing pharmaceutical environment.
The successful candidate will be experienced in compliance within
an Aseptic Fill manufacturing operation and have extensive Quality
Control processes, procedures and inspections.
- Experience should demonstrate knowledge and expertise
in Microbiology, Analytical Chemistry. Candidates must demonstrate
a thorough understanding of chemistry technologies (HPLC, AA
spectroscopy, titration, UV spectroscopy and moisture testing),
sterility testing requirements, environmental monitoring programs,
laboratory operation and documentation, FDA and ICH method validation
guidelines, as well as method development and data analysis.
- This role requires strong management and leadership
skills. Candidates must be adept at leading, develop and retain
a high performance teams driving relentless focus on their core
activities to ensure meeting department goals on time and within
- The successful candidate will have a thorough knowledge
of Good Manufacturing Practices (Cgmp), quality techniques, practices
and processes as well as all applicable federal, state and local
regulatory rules and regulations governing the Pharmaceutical
- Preference for candidates experienced with new facilities,
start-up and product transfers and more than a basic knowledge
of the validation studies required for assays and equipment.
- Prior work experience in or demonstrated knowledge
of regulatory affairs in a manufacturing pharmaceutical environment
- Experience meeting compliance requirements within
a global framework in addition to maintaining adherence to FDA
- Excellent critical thinking and troubleshooting skills
and the ability to use statistical methodologies and problem-solving
- Good general computer skills (Microsoft Word, Excel).
DESIRED QUALITIES & DELIVERABLES
The company is seeking an executive with the experience, business
acumen and commitment to establish and support the functions and
processes to ensure that products are manufactured to the highest
standards of quality.
The ideal candidate will be a well- organized, analytical, creative,
strategic thinker equally capable of tactical execution and driving
results, as well as articulating and achieving a quality vision
for the division.
- The success candidate will have the presence and integrity
to command respect and the confidence and energy to be an effective
change agent. They will have good judgment and understand how
to respond to operational and production demands and the know
how to maintain adherence to Quality Compliance within a global
- The company desires a leader with strong interpersonal
and people management skills who mentors and develops subordinates
and engenders high expectations and performance.
- The company is seeking an individual who can develop
quality compliance program plans that emphasize business planning
and accountability and implement the mechanism, processes, metrics
and reporting structure that will drive achievement of divisional
- Candidate must be able to identify quality and product
improvement opportunities and be committed to customer satisfaction.
The complete package will include a competitive base salary, highly attractive bonus program, stock options and relocation.
Mr. Larry Glines
39 South LaSalle Street, Suite 714
Chicago, IL 60603