POSITION
Director of Quality Assurance

COMPANY
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.

ENVIRONMENT
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 Operations.

REPORTING
The Director of Quality Assurance and Director of Operations report to the division's General Manager.

REPORTS RELATIONSHIPS
The role has 3 direct reports.

EDUCATION
An advanced degree in a related life science area is required and a doctorate preferred.

PERSONAL CHARACTERISTICS
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.

RESPONSIBILITIES
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.

REQUIREMENTS
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 budgets.
• 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 division’s facilities.
• 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 regulations.
• Excellent critical thinking and troubleshooting skills and the ability to use statistical methodologies and problem-solving techniques.
• 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 framework.
• 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 goals.
• Candidate must be able to identify quality and product improvement opportunities and be committed to customer satisfaction.

COMPENSATION
The complete package will include a competitive base salary, highly attractive bonus program, stock options and relocation.

CONTACT
Glines Associates
Mr. Larry Glines
39 South LaSalle Street, Suite 714
Chicago, IL 60603
312.580.0646
search@glinesassociates.com
www.glinesassociates.com