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Romark QA Compliance Officer in Florida, Florida

Description

Summary/Objective

The Compliance Officer is responsible for designing, implementing and maintaining the company’s GMP/GCP Regulatory Compliance Program for Romark.

Essential FunctionsThe position has multi-site responsibilities.

Responsibilities will include:

· Provides expertise and guidance in interpreting and implementing governmental regulations, agency guidelines and internal standards to assure compliance.

· Serves as liaison between the company and the various governmental agencies.

· Works directly with operating entities for the successful management of regulatory inspections and enforces timely completion of commitments made.

· Establishes and ensures operating entities achieve and maintain appropriate levels of compliance and assesses actions to ensure ongoing performance is achieved and maintained through metrics and other forms of KPI’s. Ensure compliance to cGCP and other regulatory requirements with regard to the clinical quality program.

· Develops and establishes the company audit program (internal and external audits)

· Aid in formulating, implementing and maintaining cGCP systems governing the Romark clinical study program.

· Provides guidance and assist in audits of clinical sites for initial evaluation/qualification for clinical trials, conducting routine audits during the clinical trials.

· Conducts the Quality Management Review with company executives

· Provides guidance in the investigation of non-conformances with potential impact to product quality.

· Provides guidance to the Quality Staff functions. Attend training seminars and industry group functions to ensure cutting edge knowledge of cGMP/GCP and current industry trends.

· Other duties as assigned.

QualificationsEducation and/or Experience

· B.S. in Life Sciences or Chemistry, or JD.

· 10+ years of operational quality and manufacturing experience in a pharmaceutical or biotech environment

· Previous GMP/GCP auditing experience

· Experience in managing contract service providers or working in a contract manufacturing, contract packaging and clinical laboratory environment

· Must be able to develop solutions to problems of unusual complexity, which requires a high degree of ingenuity, creativity and innovativeness. Challenges are frequently unique and solutions may serve as precedent for future decisions which effect the entire organization.

· In depth expertise in U.S., EU and international GMPs. Must understand standards of practice for the manufacture of solid dosage forms.

· International expertise with GMPs and international regulatory agencies is required in addition to the knowledge and application of best practices.

· Able to develop solutions to problems of unusual complexity, which requires a high degree of ingenuity, creativity and innovativeness. Challenges are frequently unique and solutions may serve as precedent for future decisions which effect the entire organization.

· A ble to interpret, execute, and recommend modifications to companywide policies to achieve corporate goals and objectives.

· Possess effective communication skills and the ability to deal across several multinational agencies and organizations.

· Able to communicate a vision, focus and direction to align organizational and individual action and achieve results.

· Promotes an open and “learning” culture that enables individuals to reach their maximum potential and builds the capability of the organization.

· Microsoft Office Suite proficiency (Word, Excel, PowerPoint)

· Demonstrated ability to deal with confidential information.

· Ability to work as part of a team and independently; displays a commitment to service, be process oriented, and have a sense of urgency balanced with good judgement.

· Individual will be a professional who is able to prioritize multiple and changing responsibilities while being organized & detail oriented.

· Able to display effective interpersonal skills with all levels of employees, from a variety of different backgrounds and cultures, as well as the ability to positively and effectively communicate, verbally and in writing.

· Strong integrity and work ethic are critical.

· Ability to build relationship with supplier base and co-workers.

· Ability to anticipate problems.

Travel • Requires up to 33% travel.

Core Competencies • Technical Capacity• Leadership• Business Acumen• Strategic Thinking• Teamwork Orientation• Problem Solving/Analysis• Project Management• Performance Management• Presentation Skills• Communication ProficiencyRomark Core Values • Vision - Big vision, no limits; purpose-driven; ability to identify potential problems or impediments and to see through them• Competence - Exceptional knowledge and understanding of the work we are called to do; exceptional critical thinking skills• Ingenuity - Original, creative, clever, innovative, perceptive and/or intuitive in solving problems or meeting challenges• Courage - Willingness to take calculated risks to accomplish a noble mission• Passion - Intense compelling enthusiasm or desire to achieve our calling/fulfill our purpose• Integrity - Having a clear vision and understanding of that which is right and doing it; being faithful to patients and healthcare professionals• Relationships - Trusted business partners, engaging others with professionalism, grace and respect in valued long-term relationships• Personal Responsibility - Leadership, dependability, doing our jobs and going beyond the call to ensure success of the organization• Respect -Humility; exhibiting special appreciation for medicines, for our work, for the responsibilities and opportunities with which we have been entrusted• Perseverance - "In it to win it" – steadfast despite difficulty or delay• Excellence - Being outstanding or extremely good in everything we do

Qualifications

Education

Required

  • Bachelors or better in Biology

Preferred

  • Bachelors or better in Chemistry

  • Doctorate or better in Law

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