1-888-4MIKART

Vice President, Quality/Regulatory

Education:
BS in related science or similar technical discipline is required. MS is preferred.
Location:
Atlanta, GA 30318 US (Primary)
Career Level:
Senior, Executive or Top-Level Management
Category:
Quality
Job Type:
Full-time
Job Description:

The Vice President of Quality/Regulatory oversees all facets of the company’s Quality and Regulatory functions and for ensuring that all products are manufactured to meet appropriate standards for quality and consistency and are processed in compliance with applicable regulations and Standard Operating Procedures.  The Vice President of Quality/Regulatory will be a member of the Senior leadership team and report directly to the Chief Executive Officer (CEO).

Accountabilities

  1. For setting the Mikart standards for Quality by analyzing regulatory authorities’ programs and activities in areas relevant to Oral Dosage products.
  2. For establishment, maintenance and assessment of the Mikart Quality Systems and for compliance to those standards of Quality and EH&S, for your departments.
  3. For the strategic throughput/capacity planning with site executive team.
  4. For establishing a sustainable, agile organization for the testing and timely disposition of commercial and clinical material to allow shipment to customers on time by having capabilities that are aligned with business needs.
  5. For supporting the commercial function in the assessment of new opportunities and providing Quality input to customers during customer visits.
  6. For the establishment and optimization of the department fixed cost, variable cost and capital budgets striving to have the Quality and Regulatory organizations contribute to Mikart profitability. Reporting against and justifying variances.

Key Responsibilities

  • Evaluate capital expenditures necessary to maintain or improve departmental operations. Compile and review annual salary and capital budgets.
  • Interface with regulatory officials during plant audits.
  • Prepare and review documents for submission to FDA, DEA, and other government agencies, as needed.
  • Proactively develop and sustain strong relationships with top management of local/regional/national regulatory authorities.
  • Evaluate the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement.
  • Maintain relations with customers to aid in compliance with regulations or development of new products.
  • Direct team of senior managers and professionals within Quality and regulatory who are responsible to hire and develop employees within the department in support of company objectives. Work with internal stakeholders in manufacturing, process development, project management, etc. to facilitate successful customer management.
Job Requirements:

Key Characteristics

  • Ability to work by influencing peers and their reports and gain their cooperation in dealing with multiple priorities in the management of compliance.
  • Strong analytical and problem solving and decision-making skills.
  • Strong communication skills and client-facing interpersonal skills. Rational persuasion particularly in the discussions with customers.
  • Strategic leadership and thinking to ensure compliance is delivered cost effectively.
  • The individual selected for this role must be independent and have a depth of experience in managing all of the quality aspects associated with clinical and commercial GMP manufacturing.

Education and Qualifications

  • S. in a scientific/technical discipline with 11to 15 years’ experience in a significant leadership position within the biological and/or pharmaceutical industry.
  • 10 years’ experience in a senior Quality leadership role required, preferably for a contract manufacturer.
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to Oral Dosage or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
  • Ability to read, analyze and interpret business periodicals, common scientific, professional and technical journals, governmental regulations and legal documents.
  • This role will be based in Atlanta and some travel will be required.

Direct Reports

Director of Quality Control, Director of Quality Systems, Director of Quality Operations and Director of Regulatory Affairs.

Apply and Submit Resume/CV.