Vice President Quality & Regulatory

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Job description

Job Description

Directs and coordinates activities of the organization to obtain optimum quality & compliance of clinical operations and maximize profits by overseeing the following activities of departments such as Quality Assurance, Quality Compliance & Quality Control, either personally or through subordinate Managers and Supervisors.

PLANNING

Support the company objective and philosophy of business and keep it current.

Contribute annually by August 1, in the development of the company goals, objectives and financial plans to be achieved for the next fiscal year.

Collaborate in a company budget by August 31, and implement through Department Managers.

Review annual Manpower Plans.

Review budget variance reports and take corrective action as necessary.

Direct and coordinate promotion of products and services performed to develop new markets, increase share of the market, and obtain competitive position in the clinical supply chain industry.

Confer with administrative personnel and review activity, operating, and sales reports to determine changes in programs or operations required.

Direct preparation of directives to department managers outlining policy, program, or operations changes to be implemented.

Promotes organization in industry, manufacturing or trade associations.

MARKETING AND SALES

Analyze Eurofins CTS strengths and weaknesses in the market and ensure that marketing and sales plans emphasize the company's strengths and overcome its weaknesses.

Recommend the addition and deletion of service lines, consistent with need and market expectations.

Recommend all policies regarding minimum order amount, payment terms, customer and quantity discounts.

HUMAN RESOURCES

Review and recommend to the President the organizational needs of the company and implement approved changes.

Review with each key Manager the strengths and weaknesses of each functional area and direct action as required.

Recommend the establishment of compensation and bonus programs that are cost effective and insure that competent employees are attracted to and retained by, the company.

Support all safety and corporate training programs.

Approve PTO schedules of direct reports.

Support all company policies and procedures.

Approve all wage and salary increases over plan.

Approve all hires outside the manpower plan.

Provide each direct report with a formal performance review per company policy and ensure all employees are given performance reviews per company policy.

Ensure that all managers and supervisors are trained and aware of the company's employment policies, rules and regulations and of government laws relating to employee relations, hiring and firing.

Ensure that all job descriptions and performance criteria, within the company, are reviewed and updated as required.

QUALITY & COMPLIANCE

Recommend all department Capital Expenditures to the President.

Recommend all department Equipment Leases and subcontracting to the President.

Approve all daily and weekly schedules set by departments which will not meet customer delivery requirements.

Ensure that backlog information and input/output statistics are developed and published monthly.

Approve changes in schedules made to expedite customer orders

Approve all delivery dates for delivery shorter than standard lead time.

Recommend all Maintenance Contracts to the President.

Approve the transfer of people between Managers to meet schedules.

Approve all hardware and software selections for computer operations.

Approve all software modifications costing over $1000.

Review as required the computation of material needs and take correctiveaction if required.

Develop QMS policy and processes to ensure all quality standards are in compliance with FDA and all competent authority regulations and requirements.

Oversee audit process, including focused and general audits of Operations and Quality Assurance areas against cGMP standards and ensures resolution of any identified issues.

Draft, edit, compile and obtain internal approval of routine correspondence regarding regulatory filings, such as INDs, BLAs, NDAs and related supplements and amendments.

Establish training matrix for all employees and ensures training is on track and up to date.

Review technical problems, procedures, complaints and non-conformance of departments, recommends corrective and preventative actions to problems and changes to procedures to ensure high quality is the company standard.

Visit and audit material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders and vendor quality standards.

Monitor the external environment and identify opportunities to fulfill the corporate quality strategy.

Review batch record templates and initiates modifications when necessary.

Collaborate with other departments and management to set safety standards.

Ensure the department is compliant with cGMP and all competent authority guidelines by regularly reviewing and directing the update of SOPs.

FINANCE

Approve all purchases, for the department, for expense items over $500.

Review and recommend all equipment purchases for the department.

Approve all expense reports for department personnel.

Approve all repair, for department equipment, over $500.

Recommend all maintenance contracts, for department equipment, to the

President.

OTHER

Monitor all installations of computer hardware and software, for production, ensuring that they are timely and cost effective.

Improve your knowledge of clinical supply operations and response industries and their production methods by outside reading, seminars and workshops.

Ensure that all departments in Operations are maintained neatly and orderly.

Perform other duties as directed by the President.

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