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VP of Regulatory & Quality

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Company: Scientific Search

Location: Chester, PA

Date Posted: August 29, 2014

Source: ZipRecruiter

Company Description:
Since 1983, Scientific Search has been placing technical, management, and executive level professionals. We have been named one of the fastest growing, privately held companies in South Jersey by the Philadelphia Business Journal six times, and one of the prestigious Philadelphia 100 companies on four occasions including this past year. We are also a member of the nationally recognized Inc.
5000.

Job Description:
VP of Regulatory & Quality
- Chester, PA area:

Objective:
Leads the development, implementation, and direction of effective regulatory strategies with oversight for all of quality and compliance for the companys traditional compounding pharmacy as well as the companys newly created Outsourcing Facility. Critical features of this job are described under the headings below. They may be subject to change at any time due to reasonable accommodation or other reasons Essential Duties &

Responsibilities:

1. Track and evaluate governmental (FDA, DEA, etc) and State Board of Pharmacy regulations ...

Company Description:
Since 1983, Scientific Search has been placing technical, management, and executive level professionals. We have been named one of the fastest growing, privately held companies in South Jersey by the Philadelphia Business Journal six times, and one of the prestigious Philadelphia 100 companies on four occasions including this past year. We are also a member of the nationally recognized Inc.
5000.

Job Description:
VP of Regulatory & Quality
- Chester, PA area:

Objective:
Leads the development, implementation, and direction of effective regulatory strategies with oversight for all of quality and compliance for the companys traditional compounding pharmacy as well as the companys newly created Outsourcing Facility. Critical features of this job are described under the headings below. They may be subject to change at any time due to reasonable accommodation or other reasons Essential Duties &

Responsibilities:

1. Track and evaluate governmental (FDA, DEA, etc) and State Board of Pharmacy regulations and their impact relative to the current and future business.
2. Oversee the companys global regulatory and quality strategies and policy development.
3. Directs the functional resources related to these areas and provides on-going, hands-on expertise.
4. Develops and implements comprehensive regulatory strategies for the companys existing and newly created businesses.
5. Assures all pharmacy expansion designs meet the requirements and expectations of the FDA and State Board of Pharmacy guidelines and regulations.
6. Reviews proposed changes to regulated processes and / or products to identify regulatory implications.
7. Provides direction for significant deviation events that may impact compliance status.
8. Ensures compliance with all state and federal laws and regulations, including licensure and certification requirements.
9. Reviews Final Reports, Traditional Compounding Pharmacy and Outsource Facility Process Documentation, Clinical Protocols, and related documentation for compliance with cGMPs, USP 795 and/or 797, and other appropriate regulations and guidelines.
10. Manages and provides internal training for FDA and State Board of Pharmacy guidelines and regulations.
11. Acts as primary liaison for inspections and coordinates meetings with FDA, CDER, NABP, State Boards of Pharmacy, National Home Infusion Association and other regulatory agencies and related advocacy associations, including attorneys and consultants retained for the purposes of performing mock audits as needed
12. Represents the company with all domestic and international health authorities.
13. Interacts with key scientific, clinical research, and commercial personnel within and outside the company to ensure timely and accurate regulatory compliance.
14. Communicates the companys position to internal stakeholders and external partners.
15. Provide organizational leadership for worldwide regulatory and quality professionals.
16. Prepares and submits applications and reports
17. Coordinates and prepares document packages for regulatory submissions ensuring compliance with the FDA.
18. Prepares responses to inquiries from regulatory authorities.
19. Handles budget requirements and monitor project and program costs.
20. Determines the need and arranges for mock FDA SBOP audits.
21. Serves as point person for FDA and State Board of Pharmacy audits. Non Essential Duties and Responsibilities
Perform other duties, special projects as assigned Authority and

Accountability:

Manages staff in QA, Regulatory and compliance functions on a daily basis providing guidance, training, and direction of staff operations. Skills, Competencies and

Experience:
Required
15 20+ years of experience in the sterile compounding pharmacy and/or sterile pharmaceutical/biotech manufacturing industries demonstrating expert skills and successful results orientation in all phases of regulatory interactions with federal and state agencies.
Experience in leading the Quality function.
Excellent communication skills; team member that can work collaboratively with colleagues across all functions.
Excellent analytical, presentation, and writing skills are required. Senior managerial experience in a hands-on, small company environment.
Demonstrated experience in the strategic design, implementation and management of domestic internal audit strategies
Demonstrated knowledge of complex US Federal, state and local and international laws and regulations, including Government Contracting requirements. Preferred
Direct contact and negotiation experience with the FDA and State Boards of Pharmacy. International experience is a plus.
Experience with both the commercial sector and government contracting environment.
Familiarity with International Audit standards.
Demonstrated Forensic Audit experience, CFA preferred.
Familiarity with Information Technology (IT) Audit concepts (e.g. COBIT).
Business acumen to understand business risk and challenges, and recognizing corporate opportunities.
Ability to understand the implications and consequences of business decisions and to provide counsel accordingly.
Demonstrated commitment to sound business ethics/integrity and a commitment to corporate responsibility.
Ability to develop the trust of the Board and ICF Leadership and key stakeholders.
Excellent communication skills with an ability to motivate others and communicate with all levels of management.
Attention to detail, with outstanding levels of accuracy dealing with complex financial information
Ability to work with a team in a fast paced environment to meet strict deadlines while managing multiple priorities
Advanced knowledge of MS Office (in particular with Excel)
Prior experience as lobbyist and/or connections with appropriate political personnel. Education, Certifications,

Trainings:
Required Degree in scientific discipline; advanced degree preferred. Preferred Regulatory Affairs Certification, Certified Quality Auditor

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