Director, Quality and Regulatory Compliance

(Job Id W315551)
Posted on 3/29/2010
Location:

Winston-Salem, NC


Job Type:

Full Time


Salary: $70000.00 to $80000.00/year
Degree: Bachelor of Science
Job Description
Company seeks a leader for their Quality Program who has 5+ years experience in tissue, medical devices or pharmaceuticals and a good knowledge of FDA regulatory standards. Must be able to read, understand and interpret FDA standards, maintain and bring products into compliance with these standards. This is a full time staff position and a BS Degree is required.

The ideal candidate will have worked in the medical device, tissue bank or pharmaceutical industries and will be able to competently apply the regulatory rules to the companys diversified service and product environment.

The right candidate will be a doer that while focusing on compliance, can still be nimble enough to be responsive to new opportunities. This individual must establish a quality control program for the company which recognizes that it is a time sensitive production logistics operation.

Responsibilities associated with this position include:
1) manage laboratory activities and associated projects including assignment, organization, and tracking.
2) Monitoring of overall activities within the laboratory, including active participation
in development of products.
3) Compile, analyze and graph data for all laboratory functions.
4) Assure adherence of acceptable industry practices including: GMPs,
GTPs, USP, QSR by staff during execution of all tasks.
5) Evaluate, review, mentor, train and manage personnel performance.
6) Review/Approve laboratory documentation, complaint and failure
investigations, and laboratory studies.
7) Plan and organize projects required to achieve group and corporate
objectives.
8) Participate in budget process, monitoring group spending. Including cost
analysis/cost reduction.
9) Serve as a technical expert on methods preformed in the group; participate
in cross-functional teams to accomplish business objectives.
10) Ensure efficient functioning of tissue processing activities.
11) Prepare reports to inform management on quality issues.
12) Lead the development and validation of methods used for testing
13) Acts as a Change Agent with the ability to influence at all levels of the
organization
14) Other duties as requested by the Quality Control Director.

QUALIFICATIONS:
Requirements: BS in Engineering or life sciences (preferred) or allied fields with a
minimum of 5 years experience in regulatory compliance, regulatory affairs
and quality systems in the tissue banking and/or medical device industry.

Solid experience and proven track record in FDA successful submissions
of 510k, IDE and PMAs. Exhibited project management and leadership skills.

Demonstrated leadership, communication and presentation skills. PC and /
or Macintosh computer literate, Working knowledge, Windows/Mac OS, MS
Office Suite.

Must be able to lift/carry 25-30 lbs; Wear gloves, face masks, respirators,
and clean room attire.

Knowledge of applicable testing and/or calibration equipment.