Director of Quality - Windsor, CT | Biospace
Get Our FREE Industry eNewsletter

Director of Quality

SCA Pharmaceuticals

Location:
Windsor, CT
Posted Date:
6/13/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Manufacturing/Production, Pharmaceutical, Quality,

Job Description

Description
The Director Quality is responsible for establishing the Company’s quality philosophy, policies, practices, procedures, standards, processes and systems by which all Company operations are performed. This position is the site Head of Quality having ultimate authority for the site decisions affecting product quality and sustainable cGMP compliance. This position is responsible for assuring compliance with DEA and FDA regulations, cGMP’s and applicable department programs, including training, documentation, and standard operating procedures. This position provides leadership, direction and coordinates all quality activities in accordance with the policies, goals and objectives of SCA Pharmaceuticals.

Key Responsibilities
•   Ensures that all products compounded at the site are produced, tested, and released in compliance with SOPs, cGMP and FDA regulations.
•   Ensures systems, resources, and action plans are reviewed and decisions made to attain sustainable compliance.
•   Facilitates interactions between Quality, Pharmacy and Operations teams in order to help set and meet customer’s timelines while maintaining compliance.
•   Manages full batch rejection and recall decisions in conjunction with Site Leadership Team.
•   Oversees the establishment of all systems, procedures and specifications affecting product quality (e.g., batch records, SOPs, and validation protocols) to minimize errors and eliminate the possibility of non-compliant products being produced or released.
•   Provides leadership and direction and ensures achievement of all functional accountabilities for the following units: Quality Assurance, Quality Control, Microbiology and Validations.
•   Is the primary contact with the FDA field operations and District Office staffs and leads FDA inspections.
•   Directs initiatives that accomplish continuous improvement and cost effectiveness and enhance efficiencies and compliance of processes and procedures.
•   Oversees the Quality functions in regard to human resources including determining the strategic staffing plan, interviewing and selection, organizational development, managing resources, mentoring and coaching and counseling and performance management and compensation.
•   Ensures that all Quality team members are trained in cGMP, SOPs, company policies and safety and that those employees meet the qualification requirements.
•   Develop and implement the management of SOP and GMP training programs.
•   Cost improvement planning of QA & QC department to increase productivity and efficiency of quality unit while maintaining compliance.
•   Prepare the site for participate and oversee on-site regulatory, customer and third party audits.
•   Communicate to VP of Quality any critical cGMP and/or non-compliance issues in a timely manner.
•   Stays current with regulatory guidance
•   Experience in the following functions, auditing/inspecting, data and document review, internal and external inspection.
•   Is a contributing member of the leadership team and engages in business decision making from a Quality perspective.

Requirements

Qualifications
Knowledge: Familiarity with regulatory requirements for a 503B Compounding Outsourcing Facility, or applicable experience in sterile pharmaceutical, medical device, or biotech manufacturing.

Skills: Leadership, critical thinking and decision-making, effective communication, customer focus, business astuteness, process orientation and risk management skills.
•   Minimum: 4 year degree in life sciences, engineering, or related discipline.
•   Minimum: 5 years of management experience.
•   Minimum: 10 years of quality experience in pharmaceutical, medical device or other related industries.
•   Experience in leading quality organizations to meet quality metrics and financial commitments. Identify problem areas and actions for elimination/mitigation of issues.
•   Experience interacting with regulatory agencies (e.g. FDA, notified bodies, etc.).
•   Strong business insight with the ability to analyze and solve complex business issues.
•   Proven ability to work cross-functionally to achieve business outcomes.