Quality Assurance Site Manager Job

Employer Name: Confidential	SpiderID: 2471651
Location: Green Bay, Wisconsin	Date Posted: 9/5/2008
Wage: $100K—$120K	Category: Biotech
Job Code: 3130

Job Description:
Our client is the healthcare division of a leading Fortune 500 company that has developed a reputation for successfully bringing complex products to market in a variety of areas. The organization has some of the strongest financial indicators in the industry and a world-class program for ongoing employee development. This is an incredible opportunity for someone that wants to put their drive and initiative to work.

Job Responsibilities:
1) Ensure full quality and regulatory compliance of a facility, while driving process effectiveness and efficiency at the site
2) Prepare and execute quality management system reviews
3) Ensure site audit readiness and host the quality system audits
4) Exercise authority to stop production, issue product holds (stop orders) and make decisions about budgets and people accountability
5) Release products and sign off on project milestones (i.e. new product introduction)
6) Maintain positive agency relationships/liaisons with regulatory agencies upon site inspections and participate in external technical forums
7) Oversee site compliance assessment and remediation plans while influencing site execution, functional policy, local research and development programs as well as communications and training requirements for quality matters
8) Ensure site education of non-quality assurance reports along with professional development of the site Quality Assurance Team

Job Requirements:
1) Bachelor's degree (or High-School Diploma/GED with 4 years of working experience and understanding of product development, manufacturing, quality control and servicing in a medical device environment)
2) Minimum 1 year of supervisory/management experience
3) Minimum 3 years of quality assurance/regulatory assurance experience in the medical device or pharmaceutical industry
4) Expertise in regulations in the medical device and/or pharmaceutical industries
5) Prior experience in using word processing, spreadsheet and presentation software
6) Knowledge of quality management system tools, continuous-improvement methodologies as well as site level products and related processes
7) Proven managerial/leadership skills such as work planning, delegating and evaluating
8) Ability to effectively communicate within all levels of the organization about concepts of design controls, production and process controls, CAPA, complaints and risk management and product quality improvement using tools such as Six Sigma, DFR, etc.
9) Superb collaboration, negotiation and conflict-resolution skills
10) Excellent oral communication skills as well as report, business correspondence and procedure-writing skills
11) Proven mentoring and coaching skills with ability to motivate and inspire others
12) Proven leadership skills (experience successfully managing people/projects/issues)
13) Effective interpersonal, teamwork and networking skills
14) Exceptional analytical, problem-solving and root-cause analysis skills
15) Ability to lead, acknowledge, develop, communicate and implement a strategy under crisis situations to ensure compliance
16) Ability to be an agent of change with energy, passion and enthusiasm
17) Ability to make decisions under pressure and be accountable for assigned projects and programs
18) Ability to multi-task and handle tasks with competing priorities effectively
19) Ability to energize others by building a connection with the team through personal involvement and trust as well as by providing feedback and coaching to help develop others
20) Ability to simplify strategy into specific actions with clear accountability as well as make decisions with speed and accuracy based on best available information
21) Willingness to travel to company headquarters as needed

Applicants are encouraged to apply directly by going to: http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-03130.html

Job Criteria:
Start Date: ASAP
Position Type: Full-Time Permanent
Years of Experience Required: 2
Education Required: Bachelors
Overnight Travel:
Vacation Time:

Company Profile:
Our Life Sciences practice provides executive search and recruitment services to pharmaceuticals, medical devices, and biotech industries. We represent venture capital firms and their portfolio life science and contract research companies in matters of executive search and corporate development.

Contact Information:

Contact Name: Jennifer Huston	Company Type: Recruiter
Company: Sterling-Hoffman Life Sciences

City: Toronto
State: Ontario
Zip: M5G 1T6

Web Site: http://www.sterlinglifesciences.com/