Vice President Quality Regulatory

Job Description

Like the look of this opportunity Make sure to apply fast, as a high volume of applications is expected Scroll down to read the complete 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 ensure 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 corrective action 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.

Qualifications :

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelors' Degree in related sciences or equivalent experience in quality or compliance in pharmaceutical or biotech manufacturing, MBA preferred.
• 4 - 7 years experience in quality or compliance in pharmaceutical or biotech.
• 2 - 3 years management experience leading medium size teams.
• Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines.
• Excellent oral and written communication is required to communicate with the team, peers, management and external contacts.
• Proficient with interpreting and implementing cGMPs.
• Strong leadership to mentor and develop team to achieve Company goals.
• Strong knowledge of personal computers and Microsoft Office Products, including Word, Project and Excel.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use hands to finger, handle or feel and talk or hear and frequently required to sit.

Employee is occasionally required stand, walk and reach with hands and arms. The employee must occasionally lift and / or move up to 10 pounds.

Specific vision abilities required by this job include close, distance and ability to adjust focus.

Additional Information

We support your development! Do you feel you don’t match 100% of the requirements? Don’t hesitate to apply anyway! Eurofins companies are committed to supporting your career development.

We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer.

We prohibit discrimination against employees or applications based on gender identity and / or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique.

Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives.

We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal!

Find out more in our career page : https : / / careers.eurofins.com /

Company description : Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable.

From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

J-18808-Ljbffr