Senior QA Director

Essential
Duties and Responsibilities:

Summary of Position

Oversees
the development, implementation and maintenance of quality assurance systems
and activities. Assists with the development and management of a company-wide GxP
system of Quality Assurance. 

Utilizes quality tools
such as lean six sigma, risk management, and other tools to continually
improve operations and to assure compliance with all appropriate
federally-mandated requirements as well as industry benchmarks.

Manages
audits of GxP activities. Coordinates interdepartmental activities. May lead
investigations and resolve potential product quality issues to improve
efficiency. Selects, develops, and evaluates personnel and vendors to ensure
the efficient operation of the function.

Assures
inspection preparedness and leads company representation during GxP
inspections. Works with QA colleagues and company management.

Serves as a key contributor
in SOP/process document development and maintenance.

Responsibilities

• Functional
leadership including managing vendor support

• Approve Deviations
and CAPAs

• Provide support for
audits and regulatory inspections

• Perform change
control assessments Quality Systems including document management, change
control, CAPA

• Contributes to
SOP/process document development and maintenance, ensuring compliance with
regulations and industry benchmarks

• Develops and
implements annual quality plans, departmental goals, action plans, and
budgets according to Shanton requirements

• Independently
reports quality metrics to executive management through a management review
process

• Support talent
management including recruitment, selection, development, training &
retention of quality staff and ensures that proper quality skill sets and
competencies are consistent with business and development plans

• Collaborates with
process development, manufacturing, supply chain, commercial, corporate, and
clinical groups

• Assures team quality
training system is effective

• Ensures all
deviations/change controls from established procedures are appropriately
documented and investigated to determine and address root cause

• Other duties as
assigned

Qualifications

• Experience in
pharmaceutical field required

• Extensive working
knowledge of quality system requirements such as US FDA GxP, EMA, and ICH
guidelines and has a proven track record of successfully implementing these
requirements

• Demonstrated ability
to successfully interact with regulatory health authorities at inspections

• Ability to lead and
influence cross functional employees to ensure compliance

• Ability to
effectively present information in small and large group situations to staff,
customers, regulators, and executive management

• Excellent
interpersonal, verbal and written communication skills are essential in this
collaborative work environment

• Proficient in MS
Word, Excel, Power Point

• Certifications (preferred):

CQA (Certified Quality
Auditor)

CPGP (Pharmaceutical
GMP Professional Certification)

RQAP GCP and GLP (refer
to the Registered Quality Assurance Professional credential, which is a
recognized standard of experience and knowledge in the QA industry. It is
available for professionals working in Good Clinical Practices
(RQAP-GCP) and/or Good Laboratory Practices (RQAP-GLP). 

Education
and/or Work Experience Requirements:

• Minimum experience
of 20 years in a technical role in quality assurance, manufacturing, QC or
quality engineering

• 10+ years of staff
and/or vendor management experience

• Master's degree in
engineering, chemistry, or biological sciences required. Advanced degree preferred