Executive Director, Quality Assurance

Intercept Pharmaceuticals   •  

San Diego, CA

11 - 15 years

Posted 237 days ago

This job is no longer available.

Job ID:  489

The Executive Director of Quality Assurance (Global GXP) has overall strategic and functional responsibility for quality assurance, quality systems, and oversight and reporting on global corporate GXP compliance. This position reports to the Sr. Vice President, Technical Operations. It is a full-time position requiring a broad range of QA experience in GMP, GCP, GPvP, and GLP working with internal collaborators and external vendors. This position also collaborates with internal, non-GXP functions (e.g. Legal, HR, Finance, IT) in the execution of QA department activities and ensuring alignment where GXP and non-GXP systems meet. This position requires knowledge of global applicable regulations as well as industry and company GXP standards and procedures. The individual in this position is responsible for leading the QA team, which develops, applies, and maintains quality standards for the company and its vendors for adherence to applicable regulations/standards. This position develops inspection readiness strategies and leads inspection readiness projects. It requires domestic and some international travel.

ESSENTIAL FUNCTIONS:

The main strategic responsibilities are as follows:
• Guide and oversee Intercept quality during development (Phase 1 to 3) and commercial (post-marketing, Phase 4) activities.
• Provide interpretation of regulatory guidance documents, regulations, and directives and advice on applicability on internal programs and external vendors.
• Oversee compliance and identify/minimize regulatory risks across disciplines (GCP, GVP, GMP and GLP).

The following operational responsibilities are as follows:
• Develop and implement programs to improve internal quality; foster continuous improvement efforts and culture
• Department management responsibilities:
o Management and development of QA department staff/contractors
o QA department budgets
o Defining department goals and metrics
o QA department contract negotiation and review for vendors and contract staff
• Supervise/administer the following functions carried out by the QA department:
o Quality System (QS) oversight and quality metrics reporting
o Chair quality management review meetings and quality council meetings
o Management of electronic and paper GXP documentation system(s)
Internal Quality Control (QC) functions of regulatory submission documents such as IBs, IMPDs, INDs, SPAs, and clinical protocols and study reports
Internal / external QA audit program – GMP, GCP, GPvP, GLP, GDP.
Internal GXP training program
o Creation and finalization of Quality Agreements with external vendors
o External clinical and drug manufacturing vendor quality oversight

REQUIRED KNOWLEDGE AND ABILITIES:

• In-depth knowledge of the following:
o QA oversight in a GXP regulated environment for pharmaceuticals from product development through commercialization
o QA oversight of vendors carrying out API synthesis, drug product manufacturer, release and stability testing, and packaging and distribution
o Quality principles and industry trends
o CFR, ICH, and GXP regulations
• Excellent skills in the following areas:
o Written and oral communication
o Interpersonal skills
o Team player
o Proven leadership skills
o Proficient in computer applications: MS Suite, EDMS, LMS, QMS, and TMF/CTMS (as necessary).

QUALIFICATIONS:

• Bachelor’s degree in Organic chemistry, Biochemistry, or a relevant science; graduate degree preferred.
• 10+ years of QA experience in the pharmaceutical or a related FDA/EU regulated industry required.
• GCP and GMP QA experience are both required to be successful in this role.