Principal Consultant - Compliance

ProPharma Group

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Location: San Francisco, CA Posted Date: 4/30/2013 Position Type: Full time Job Code: 2013-2065 Required Education: Bachelors Degree Areas of Expertise Desired: Quality Assurance

Description

ProPharma Group is an industry leader providing validation, compliance and technical services to the pharmaceutical, biotechnology, medical device and related industries.  We offer the excitement of a consistently evolving career.  Our team is continually learning and working on new and exciting projects in a variety of regions.  We look for people who excel in their technical area of expertise, believe in our values of Experience, Integrity and Commitment and thrive in the collaborative, rigorous and entrepreneurial spirit of the company culture.  We pride ourselves on developing long-term relationships with clients across the country and providing a wide array of value-added services that complement and support their core business needs.

Responsibilities

1.   The Principal Consultant – Compliance will be subject matter lead for specific quality assurance and regulatory/GMP compliance projects within PPG.  
2.   Promote continual improvement regarding customer satisfaction with emphasis on quality and compliance services.
3.   Keep pace with advances and technological changes in Compliance Services and the pharmaceutical / device / biotech industries, and promote those that will increase the company’s effectiveness and profits.
4.   Provide support to clients and all functional units of ProPharma Group as quality and regulatory compliance issues such as deviations and non-conformances arise.  Provides consultation for the implementation of proper CAPA to resolve deviations and non-conformances.  Also, is responsible for helping to ensure compliance of company operations to quality principles and GMP requirements, and participation in the development of quality systems through SOP writing and training.
5.   The Principal Consultant – Compliance is responsible for promoting Quality and Compliance subject expertise through publications and presentations through professional networks.
6.   The Principal Consultant – Compliance will provide ongoing support and expertise to all personnel, assisting them in establishing goals, objectives, policies, and procedures for all applicable subsets of this business unit within the company.
7.   Help to ensure the Compliance practice is in compliance with all applicable internal and external policies procedures, and industry best practices.
8.   Generation of proposals for Compliance-related projects.
9.   Assist Operations in staffing client projects to enable the company to execute the strategic plan efficiently and effectively, and to meet revenue and profit goals based on personnel skills development and client needs.  Includes candidate interviewing skills.
10.   Audit projects for correct approach, consistency, and quality.
11.   Ability to interact in a professional and positive manner with clients and co-workers.  
12.   Exceptional communicator with strong persuasion skills and presentations.
13.   Excellent interpersonal and communication skills.
14.   Understanding of the criteria for selection for compliance consulting services in the pharmaceutical, medical device and biotech industries.  
15.   Working knowledge of the sales process in these industries.  
16.   Ability to earn and maintain a client’s confidence through appropriate planning, organizing, controlling, and directing of a project.  
17.   Proven record with team leadership, problem solving, project tracking and budgeting, and facilitation of efficient communication between the client and the team.  
18.   Ability to organize and manage projects.
19.   Quality orientation and high attention to detail.
20.   Demonstrated ability to lead people and get results through others.
21.   Ability to think ahead and prepare action plans to achieve results.
22.   An ability to balance and achieve positive results in the areas of safety, quality, productivity, cost and employee relations.
23.   Ability to take initiative, to maintain confidentiality, to meet deadlines, and to work in a team environment. The role will guarantee the continued success of the company by ensuring that all employees, contractors and the company as a whole meet or exceed established quality guidelines.
24.   Expertise knowledge of cGMP regulations, USP standards, and ICH and FDA guidance documents.
25.   Utilize expertise of quality systems and GMP compliance to conduct audits and provide Gap analyses and risk assessments for clients.
26.   Perform Customer Service functions in response to client inquiries.
27.   Provide support to clients and all functional units of ProPharma Group as quality issues such as deviations and non-conformances arise. Also, provide advisement for the implementation of proper CAPA to resolve deviations and non-conformances.
28.   Strong editorial skills for the review and approval of GMP documentation, including protocols, reports, SOPs, etc.
29.   Effective written and oral communication skills; ability to write, type, express or exchange ideas by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.
30.   Ability to manage and mentor colleagues in company quality program and compliance related activities.
31.   Ability to manage and work with multiple individuals (where applicable); ability to manage and execute multiple tasks associated within the compliance, quality assurance and validation fields.
32.   Willingness to travel within the continental United States as well as other countries as may be required for short durations.

Requirements

B.S./B.A in Engineering or scientific discipline as a minimum.  A graduate degree in a scientific discipline is preferred
Minimum 15 year management experience in related industry.
Minimum 10 years managing a technology business or business unit or applicable related experience
Preferred:  Name recognition in the industry as a thought leader.

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