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Associate Director Corporate Compliance - Req #: 51965009
Elan Pharmaceuticals
King of Prussia, PA
At Elan, we hold a fundamental belief that
our science has the potential to improve patients' lives. Our pipeline
of developing compounds and investigative therapies reflects our
commitment to bring innovative products to patients with unmet needs in
the areas of neurodegenerative diseases, autoimmune diseases and severe
pain.
Elan's commitment to patients is reflected
in all that we do: we are a company driven by the knowledge that our
work is important and the desire to make a difference. Elan offers
prospective employees exciting challenges, unique opportunities for
career growth, and a fast-paced environment that emphasizes innovation
and achievement.
Primary Objective of Position:
The Associate Director, Corporate Compliance serves as the Élan GLP/GCP
subject matter expert and maintains knowledge of current regulatory
trends and industry 'Best Practices'. Develops and maintains compliance
metrics of all Élan facilities that support pre-clinical and clinical
studies. Monitors Élan facilities utilizing compliance risk management
strategies. Identifies problems and recommends corrective actions in
order to facilitate quality process improvement. As necessary, supports
pre-existing Élan GLP/GCP QA system monitoring activities. Ensures FDA
inspection preparedness in support of all Élan product submissions.
Major Duties/Responsibilities:
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Performs Corporate Compliance assessments at Elan sites and third
parties to assess and ensure compliance with regulatory agency
requirements, GLP's, GCP's, GMP's corporate policies/procedures (as
applicable) and site procedures. Communicates findings in formal,
written audit reports issued to Elan management. |
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Tracks and monitors Elan facility corrective actions taken as a
result of Corporate Compliance assessments. Trends corrective
actions to identify opportunities for implementation of continuous
improvement programs. |
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Manages or conducts follow-up audits to assess the adequacy of
corrective actions and other site initiatives |
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Reports potential compliance issues on a routine basis and as the
need arises, to the Director Corporate Compliance. |
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Serves as a technical resource in providing guidance to Elan sites
on compliance issues.- Assists in monitoring the regulatory
environmentfor changes, activities, etc. that may impact Elan's
operations. |
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Ensures current industry trends are utilized in performing audits,
reviewing corrective actions and evaluating site compliance |
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Other duties as assigned. |
Impact: Has a meaningful influence on
a function or a program that affects the company's finances, people or
products as they related to a facilitating a higher level of FDA
regulatory compliance, industry knowledge and resource efficiencies.
Scope: Applies ethical judgment
and professional expertise (FDA regulatory, scientific and Élan
Pharmaceuticals policy) independently. Establishes policies and
procedures that affect multiple departments. Serves as GLP/GCP
regulatory consultant of multiple departments supporting the areas of
analytical chemistry, bio-analytical chemistry, pre-clinical safety and
clinical testing.
Skills/Abilities:
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Strong
organizational, team building, leadership, management, influencing
ability, planning, conflict resolution and problem solving skills |
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Analytical thinker with the ability to work effectively
cross-functionally. |
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Excellent communication (both written and verbal), facilitation, and
presentation skills. |
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Extensive experience with analyzing compliance metrics (QA system key
indicators) in order to identify compliance concerns and continuous
improvement opportunities. |
Travel: 50% Domestic, 5%
International
Minimum experience requirements:
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Minimum
of ten years work experience in the biotechnology, device, or
pharmaceutical industry. |
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Five
years of direct GLP/GCP QA systems experience. |
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Experience as an auditor performing audits in compliance with FDA GLP/GCP
(21 CFR part 11, 54, 58, 50, 56, 312 and 812), OECD-GLP and ICH E6
guidelines. FDA cGMP (21 CFR part 211) is a plus. |
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Minimum
of three to five years experience managing the activities of direct
reports. |
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Experience facilitating FDA PAI and 'for cause' inspections on behalf of
sponsor sites. |
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Experienced in developing and maintaining metric based compliance
monitoring. |
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Proven
ability to lead/influence multi-departmental/multi-facility compliance
improvement tasks. |
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Train
on FDA regulations and auditing concepts. |
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Ability
to communicate complex concepts to a diverse audience (analyst to
executive management). |
Special Training: RQAP-GLP certified
by the Society of Quality Assurance (SQA).
Minimum Education Requirements:
Bachelor's Degree in Life Sciences. Master's Degree in Chemistry or Life
Sciences.
Contact: Phil Munkacsy Director
Corporate Compliance Elan Pharmaceuticals
Philip.Munkacsy@elan.com |