Site Head Of Quality (Gmp & Microbiology), Director Of Quality 8/9/2016

KHI Springfield, MA

Company
KHI
Job Classification
Full Time
Company Ref #
28656012
AJE Ref #
575828720
Location
Springfield, MA
Job Type
Regular

JOB DESCRIPTION

APPLY
A leading contract development and manufacturing organization is hiring. We are investing at our primary testing facility near Springfield, MA and actively seeking a site head of QA. With Capital investments adding new automated capabilities, expanding our analytical and microbiology testing capabilities and overhauling our qualitysystem - we are seeking a change agent to drive these efforts through to completion along with ensuring we have a first in class quality team to support our clientele.

Reporting to the VP of Quality, the director of quality will be responsible for ENSURING QUALITY SYSTEMS MEET DOMESTIC, INTERNATIONAL, AND CORPORATE CGMP REQUIREMENTS for the manufacture and control of PHASE 1-3 CLINICAL MATERIAL AND COMMERCIAL APIS AND DRUG PRODUCT, along with managing the QUALITY REQUIREMENTS FOR THE PREPARATION AND TESTING OF GLP TEST ARTICLES.

The Director of Quality will have responsibilities in facilitating the development, implementation, and maintenance of procedures and policies to comply with FDA, EU, and ICH requirements applicable to API and drug product in all development phases up to and including commercialization.

VISION FOR THE ROLE

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Directs the processes for the approval and rejection of all materials, test methods, specifications, SOP's, work instructions and protocols.
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Directs the processes for the review and approval of test methods validation reports, stability protocols and reports.
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Oversee the quality documentation systems to assure review and approval of Incident Reports, Change Control, and investigations.
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Directs and oversees site management of the Master Control Documentation system.
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Overall responsibility for final disposition of materials, intermediates, and release bulk API and clinical and commercial drug product.
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Overall responsibility for the Annual product and system review and presentation of status of quality metrics in a Management Review Program.
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Overall responsibility for implementation of maintenance of compliance programs and systems for GMP and GLP lots.
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Oversee the GMP internal and external auditing programs assuring that corrective actions are implemented within committed.
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Oversee the GMP supplier approval and Quality Agreement programs.
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Overall responsibility for site Master Validation Plan and site GMP validation activities including computerized systems.
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Oversee the GMP orientation, annual training program and assures that site GMP training programs and systems are in compliance with corporate and industry standards.
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Overall responsibilities for site regulatory agency inspections, response coordination and finalization and assuring any correction actions are completed.
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Works with multidisciplinary project teams and close departmental collaboration with Process Chemistry, Drug Product Manufacturing, Analytical Development, Pharmaceutical Development, Facilities and Quality Control to meet company goals.
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Directs and manages QA department employees.
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Prepares and executes QA department budget.
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Performs other duties as assigned by senior management.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

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Experience managing GMP & GLP qualitysystems and quality policies preparation.
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Extensive knowledge of FDA, EU and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry.
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Experience in qualitysystems and compliance for API and drug product.

TECHNICAL SKILLS

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Proven ability to build a strong and flexible Quality team in which the expertise resides.
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Demonstrates the capability for continued upward growth and technical contributions.
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Significant leadership and management experience in the industry.
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Experience managing GMP& GLP qualitysystems.
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Extensive knowledge of FDA, EU and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry.
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Excellent analytical and problem solving skills, with the proven ability to think strategically.

COMMUNICATION SKILLS

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Highly effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines.
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Excellent diplomatic, analytical and communication skins, both verbal and written.
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Very effective listening skills with the ability to hear attentively and process information correctly.

MANAGEMENT SKILLS

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Balances compliance requirements with business needs.
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Thinks creatively, develops and executes plans within a fast-paced environment.
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Ability to discuss and reach an agreement in a professional manner.
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Ability to manage and analyze a situation and develop a professional solution to the organization.