Are you ready to join a company with staggering growth in an exciting new industry? Do you desire to be part of a company where your hard work and contributions actually make a difference?
SCA Pharmaceuticals is a rapidly growing 503B outsourcing facility and nationwide leader in Sterile IV Admixture products. SCA is FDA and DEA regulated. Licensed in all 50 states. There are locations in Little Rock, AR and Windsor, CT.
Competitive Salaries and benefits in this rapidly growing company and industry.
SCA Pharmaceuticals is an Equal Opportunity Employer (Minorities/Females/Disabled/Veterans). To read more about this, view the EEO is the Law poster and this EEO is the Law Poster Supplement
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1117-WINDSOR CT-008: Director of Quality
Job Code: 1117-WINDSOR CT-008
Location: Windsor, CT
SCA Pharmaceuticals is seeking a Director Quality to lead Quality at a site level in a dynamic company that provides ready-to-use Sterile Admixtures to Acute Care Hospitals. The Director Quality is responsible for establishing the Company’s quality philosophy, policies, practices, procedures, standards and Quality processes and systems by which all Company operations are performed. This position is the senior most Quality person at SCA’s newly constructed large-scale facility in the Northeast and has authority for site decisions affecting product quality. The position is responsible for enabling sustainable compliance with DEA and FDA regulations, cGMP’s and applicable department programs and initiatives including training. This position provides leadership and direction to a site team that is embracing new requirements pertaining to 503B regulations and the pharmacy compounding space.
Provides leadership and direction to a team of 25 Quality professionals; grows and develops the team to meet evolving business needs; is accountable for Quality Assurance, Quality Control, and Microbiology.
Provides leadership for budgeting, staffing and organizational development of the Quality team, including the establishment of mentoring and coaching programs.
Ensures that a robust training cGMP training program is developed and administered.
Ensures that all products compounded at the site are produced, tested, and released in compliance with SOPs, cGMP’s, FDA and DEA requirements.
Improves, develops, establishes and drives contemporary Quality Systems and processes
Leads a Quality metrics program to enable a strong Management Review
Collaborate and facilitates interactions between Quality, Pharmacy and Operations teams to meet customer requirements and timelines, while maintaining compliance.
Ensures that systems, resources, and action plans are consistently reviewed and decisions made to enable sustainable compliance.
Manages customer complaints. Makes batch rejection decisions and manages recall decisions in conjunction with the Site Leadership Team.
Establishes procedures and specifications affecting product quality and oversees the development of batch records, SOPs, and validation protocols.
Is the primary contact with the FDA District Office staffs and leads FDA inspections at the site.
Directs continuous improvement initiatives to accomplish compliance, productivity, cost-effectiveness and enhanced efficiencies of processes and procedures as they pertain to Quality.
Leads the site inspection readiness program
Lead FDA and DEA regulatory inspections at the site
Provide for the management of customer and third-party audits at the site.
Prompt communication to SVP Quality any other management of critical cGMP and/or non-compliance issues.
Staying current with regulatory guidance, as it applies to the 503B and pharmacy outsourcing space.
Leads an internal audit program that is focused on prevention versus correction
Acts as a member of the site leadership team and engages in business decision-making from a Quality perspective.
Higher degree in biochemistry, microbiology, or equivalent with a minimum of 7 years of experience in aseptic processing/sterile pharmaceuticals environments.
In-depth knowledge and experience of parenteral manufacturing and all related cGMP requirements.
Strong experience in QA and QC operations; validation and end-product sterility testing and environmental monitoring.
Proven experience and at least 5 years of experience managing and leading teams.
Has previous taken the lead role in managing Regulatory inspections
Clear and effective Communicator
Strong leadership qualities
Is a self-starter and has an innate sense of urgency