Director, Quality Systems

Position Overview:

Position is responsible for ensuring site and corporate quality systems are compliant with the current Good Manufacturing Practices (21CFR210, 211).  In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.  In addition, is responsible for management of audit readiness and assisting with audit preparation, regulatory inspections, and customer audits.  Is responsible for oversite of the corporate Supplier Management program. In addition, is responsible for the corporate Quality Documentation program.  The Director will manage the Documentation system (SOPs, Forms, Specification, etc.), master batch records creation and storage, off-site document storage, and records retention.  The Director manages site and corporate Change Control process.  The Director manages site and corporate Quality Council, Critical Action Committees, and Quality Review Board meetings.  In addition, is responsible for the Quality Standard program.  Will establish QuVa franchise for Quality Systems through establishing Quality Policies and Standards. In addition, manages the Quality Systems Department budget and development of personnel.

Responsible for the support of site and company-wide objectives through the reporting of department Key Performance Indicators (KPI).  Responsible for coordination and working schedules of people and in the Quality Systems group.

Ensures people and processes comply with current Good Manufacturing Practices and company procedures.  Modifies department standard operating procedures and executes change controls to support business and quality objectives. Establishes and maintains cooperative cross-functional relationships with peers in Quality, Operations, Technical Support, Pharmacy Services, and Supply Chain to meet site and corporate objectives.

Responsibilities may include:

• Maintains a working knowledge of government and industry quality assurance regulations and standards.
• Establishes and maintains effective cross functional relationships.
• Supports regulatory inspections and customer audits for each site
• Manages the corporate and site programs (i.e. self-improvement audits) to assess and improve the state of compliance of cGMPs.
• Manage Quality Standard program.
• Manage Quality Council program.
• Manage Critical Action Committee.
• Manage Quality Review Board.
• Manage Change Control program.
• Evaluates and tracks corrective action commitments resulting from internal audit, customer audit and agency inspection observations to verify implementation and effectiveness.
• Communicates compliance trends to Senior Management.
• Maintains control of the Quality Systems department budget and reports status to management as required.
• Provides leadership to the Quality System function, manages and provides development support to department personnel
• Supervise Managers of Quality Systems employees.  Manage direct and indirect employees.

Qualifications:

• Legally authorized to work in the job posting country
• B.A. /B.S. Degree in Science or related field or significant experience.
• Ten years of experience in manufacturing operations in pharmaceutical or other related industries.  Preferably has experience with manufacturing of parenteral products.
• Outstanding written and oral communication skills
• Excellent at organization of large volumes of data
• Experience in pharmaceutical manufacturing preferably sterile injectable
• Must be able to manage multiple, parallel projects
• Expert knowledge of regulatory requirements as they pertain to Human Drug Compounding and Pharmaceutical manufacturing
• Experience in QA/QC desirable

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.