Contract / Temp to Direct / Direct Hire: Direct Hire
Country: United States
Zip or Postal Code: 53545
SHINE is immediately seeking a GMP Quality Manager, reporting directly to the corporate Quality Assurance Manager, to manage implementation and adherence of GMP requirements for the SHINE facility. The role will have oversight, product release, audits and involvement in the FDA regulatory submissions. This position will also manage the QA lab along with working cross functionally with Engineering, Operations and other groups.
The GMP Quality Manager will be responsible for managing policies, procedure development, technical report review and design documents to ensure SHINE meets GMP requirements. The role will determine FDA regulatory submission requirements and lead the submission process. Other duties include developing, implementing and managing systems and procedures for a Quality Assurance Laboratory; participating in internal/external assessments/audits conducted by regulatory bodies relating to product testing/quality.
SHINE is seeking candidates who are subject matter experts in all areas of GMP quality along with leading a team of quality professionals including hiring, training, developing, addressing performance issues and evaluating performance. The preferred candidate will have quality certifications such as CQE, Six-Sigma, or CQM/OE.
Candidates should have a Bachelor or Masters of Science degree in Chemistry or related discipline. SHINE will consider equivalent experience. In addition, a minimum of 7 years of progressive quality control/quality assurance experience managing in pharmaceutical or medical device manufacturing environment is highly desirable. We are expecting candidates have excellent knowledge of GMP, ICH, and USP regulations and guidance. This person must be able to communicate effectively with all levels within and outside the organization.
Eligibility for employment is conditioned on the applicant’s ability to qualify for access to information subject to U.S. Export Controls regulations (U.S. Citizen or National, U.S. Permanent Resident, Asylee, or Refugee). Additionally, applicant’s eligibility may be conditioned based upon meeting the Nuclear Regulatory Commission requirements for access to Safeguards Information, which typically requires a pre-employment drug test, fingerprinting, and a criminal background check.
To apply, please complete our culture survey at http://www.cindexinc.com/c/0F2F23 and separately send a cover letter and resume including salary requirements to email@example.com.
VP of Human Resources
SHINE Medical Technologies
101 East Milwaukee Street, Suite 600
Janesville, WI 53545
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