Manager, Sterility Assurance

Position Overview:

Responsible for managing all Quality Assurance and Quality Systems departments supporting all aspects of compounding sterile pharmaceuticals and regulatory compliance within the facility.  Operates within the legal and regulatory compliance, producing a quality product.  Operates the area as the manager over the QA and QS staff, coordinating roles & responsibilities and projects.

Responsibilities may include:

• Manage QA & QS supervisors by providing learning and development where appropriate
• Ability to make Quality decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
• Manages the on-time release of batches
• Manages the on-time initiation and closure of Deviations / Investigations, CAPAs, Change Controls with thorough & standardized supporting documentation
• Manages others to ensure appropriate SOPs and training documents are in place & effective
• Manages others to ensure the design and maintenance of the environmental monitoring program including environmental and personnel monitoring are adequate and in place
• Manages others to ensure QuVa quality standards are met at the site so that processes are the same as other QuVa sites
• Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
• Prepares and submits weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities
• Manages others to maintain site documents supporting the commercial manufacturing & release of sterile injectable products
• Manages the design and implementation of site policies and procedures
• Escalates to VP of Quality critical issues jeopardizing manufacturing & release of a safe & effective product that meets regulatory requirements
• Promptly communicates with Operations regarding complaints, product issues/variances
• Enforces applicable personnel policies and procedures
• Other duties as assigned

Qualifications:

• Legally authorized to work in the job posting country
• Bachelor’s Degree in Life Science or other related field
• 5-7 years prior experience in a Quality/ cGMP / FDA regulated industry
• Minimum 5 years of supervisory or management experience required
• Experience with aseptic techniques and appropriate gowning techniques supporting manufacturing of sterile injectable products
• Technical writing and communication
• Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP’s and have demonstrated strength in problem solving and resolution
• Strong interpersonal skills

To be considered:

In order to be considered for this position you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature on or before the requisition closing date.

Candidates for regular U.S. positions must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.

It is the policy of QuVa Pharma to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.