Responsible for establishing and managing the Quality Assurance programs in support of the
Manufacturing business. Serves as a member of the Quality and Compliance management team.
Provides direction in implementing our clients Compliance Program and coordinates with peers to
promote consistency in quality assurance operations, regulatory interpretation, and processes. Works with the operational teams to assure regulatory compliance and consistency with our clients policies and procedures.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Establish and manage the Quality Assurance program in support of client site, ensuring
compliance and harmonization with policies and procedures.
• Develop and maintain all required SOP's, documents, forms, and documentation required to
support business operations.
• Communicate all identified compliance and quality risks to his/her supervisor.
• Develop quality assurance policies and procedures to assure applicable regulatory
requirements are fulfilled
• Identify the need for, and assist in the development of, Corporate and Business Unit Quality
and Compliance Policies.
• Manage Quality Assurance operational groups to assure inspections and audits are accurate,
thorough, timely, and provide the correct interpretation of regulatory requirements and
corporate policies.
• Assure staff receives appropriate regulatory and management training and mentoring to enable
the execution of regulatory and management responsibilities.
• Assume a lead role in the development and presentation of regulatory training for Quality
Assurance and operations staff.
• Monitor the effectiveness of subordinate personnel in managing compliance systems and
assuring the timely completion of: (1) review and approval of records and reports; (2)
inspections of facilities and equipment; (3) investigations, (4) audits of methods, practices, and
controls; and (5) Regulatory Affairs and Compliance projects and programs. Identify and
resolve any scheduling conflicts and program priorities to assure timelines are fulfilled.
• Monitor the effectiveness of subordinate Quality Assurance personnel in reviewing Quality
Assurance reports of audits and inspections to assure proper and consistent interpretation of
regulatory requirements and corporate policies. Identify and resolve inconsistencies between
Quality Assurance audit teams should they occur.
• Assure that all records and reports are prepared, communicated, and retained in accordance
with applicable regulatory requirements.
• Serves as a liaison with operations managers to identify regulatory deficiencies, explain audit
findings, resolve conflicts, and consult on corrective and preventative actions.
• Assemble, evaluate, and report group metrics measuring compliance and quality key
performance indicators.
• Represent the corporation during regulatory and client inspections/audits
• Prepare site/operation personnel for client and regulatory audits and prepare appropriate
summaries and reports of such audits.
• Lead the preparation of regulatory and client audit responses and corrective action
commitments.
• Monitor site/operation corrective actions commitments and communicate "at risk" commitments
to management with recommendations for their timely resolution.
• Identify practices, methods, and processes for improvement and assist other operations on
related compliance issues.
• Assure vendors and suppliers identified/designated are assessed for the compliance with
applicable regulatory requirements.
• Participate in Quality and Compliance projects and programs.
• Participate in Corporate Quality Meetings, Regulatory Affairs and Compliance meetings,
intranet communications, and relevant strategic planning sessions.
• Assure that Corporate Quality and Compliance Policies are implemented and administered at
the site/operation.
• Direct activities of assigned group(s) to ensure optimum performance of the group/function.
• Responsible for personnel management activities such as: scheduling, personnel actions
(hiring, promotions, transfers, etc.), training and development, providing regular direction and
feedback on performance, disciplinary actions and preparing and delivering annual
performance and salary reviews.
• Develop short- and long-range operating objectives, organizational structure, staffing
requirements and succession plans.
• Integrate activities with those of other major organizational units (e.g., segments, departments,
functions).
• Develop and recommend departmental budget and authorize expenditures.
• Develop and oversee the implementation of departmental training programs, including
orientation.
• Ensure adherence to pertinent regulatory requirements and to departmental policies, practices
and procedures [SOPs, safety procedures and biosafety protocols].
• Communicate all identified compliance and quality risks to his/her supervisor.
• Performs all other related duties as assigned.
QUALIFICATIONS:
• Education: Bachelor's degree (B.A. /B.S.) or equivalent. Advanced degree in biological
sciences, pharmaceutical sciences, or computer sciences preferred.
• Experience: Minimum of Seven years related experience in the GMP pharmaceutical and/or
biotechnology-based industry, with a minimum of 3 years of managerial experience
• An equivalent combination of education and experience may be accepted as a satisfactory
substitute for the specific education and experience listed above.
• Strong experience and direct responsibility for management of Quality Assurance programs
and creating new programs and processes.
• Experience with direct management of QA audits and inspections as well as interfacing with
clients and regulatory agencies and preparing/reviewing responses to any inspectional findings.
• Strong knowledge of pertinent national and international regulations pertaining to the
pharmaceutical and biotechnology industries.
• Strong knowledge of computerized system compliance, validation, and data integrity
requirements.
• Demonstrates strong leadership ability, communication, and facilitation skills with both internal
and external client personnel.
• Skilled in process optimization and continuous improvement