Sr Dir Quality

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

SUMMARY OF POSITION:

The Sr. Director, Quality is responsible for a broad range of duties/functions that includes all Quality functions at the St. Louis Plant, and the Centers of Excellence for Microbiology, Elemental Impurities, and Validation, to support the Generics Business

The Sr. Director, Quality is responsible for ensuring cGMP compliance and product quality at the Saint Louis, MO facility while supporting broader site quality initiatives aligned with company objectives. This role provides strategic leadership in the development, implementation, and oversight of site quality systems to ensure that all manufacturing, testing, packaging, storage, and distribution activities meet regulatory standards and deliver the highest product quality. The Sr. Director leads and mentors quality assurance and quality control teams, oversees daily quality operations, and serves as a key partner to site leadership by providing guidance on quality and compliance across the organization.

St Louis Plant Quality

Responsible for and will develop, establish and maintain quality systems programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure customer satisfaction. Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance. May serve as liaison between the company and the various governmental agencies. Work directly with operating entities to ensure that inspections and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.

Establish and ensure appropriate Quality Systems are implemented and maintained, including ongoing data analysis of product and process outputs to ensure early detection and response to quality concerns, and prevention of quality issues. Establish and ensure compliance with cGMPs, good housekeeping practices, employee hygiene and equipment sanitation; analyze plant error, salvage, spoilage reports and process statistics for significant findings and conclusions; work with Research and Development during new product start-ups, and establish key checkpoints for new products and processes

Centers of Excellence for Microbiology, Elemental Impurities, and Validation

The Sr. Director is responsible for Centers of Excellence for Microbiology, Elemental Impurities, and Validation to support the Generics Business. Will develop policy, create systems, develop strategies and minimize costs while striving for excellence in customer service. Establishes and maintains positive and mutually rewarding relationships with internal and external customers of the department. The Sr. Director will be also responsible for oversight and management of the training department to include all NEO, CBT and OJT systems in alignment with company policies and procedures.

ESSENTIAL FUNCTIONS:

St Louis Plant Quality Departments

• Manages all aspects of plant Quality Systems including, CAPA, Supplier Quality, Change Control, in-process Quality Assurance, Quality Control, complaint management and validation functions.
• Support an aggressive Quality program which instills personal accountability for accuracy, consistency and completeness for all operations and departments according to site and corporate policies. Create and maintain an environment of excellence, world-class quality and continuous improvement throughout the entire plant.
• Responsible to make fact-based, scientifically sound, quality decisions regarding products manufactured at the St. Louis Plant facility. These decisions must be made within the requirements of cGMPs and applicable regulatory/industry guidance documents.
• Manage approval or rejection of starting materials, packaging materials, and intermediate, bulk and finished products per the appropriate regulations and documents.
• Ensure the evaluation of batch records and that all necessary testing is carried out.
• Approve specifications, sampling instructions, test methods and other QC procedures.
• Ensure the authorization of all controlled documents, including records retention.
• Ensure the monitoring and control of the manufacturing and Quality Control environments.
• Ensure compliance with cGMP standards.
• Ensure the appropriate process, equipment and facility validations meet expectations for validations, process capability, corrective actions and general compliance both for Corporate and for applicable regulatory agencies.
• Coach and develop the team to High Performance while fostering a culture of team ownership.
• Ensure team compliance with all policies, procedures and site/company regulations.
• Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member's performance management.
• Exhibit accountability and responsibility for an area or process in order to affect change and lead efforts and ideas to completion.
• Provide leadership for employee relations through effective communications, coaching, training and development and eliminate roadblocks in order for the team to move forward.
• Supply the highest level of internal and external customer service while having the ability to diplomatically challenge established procedures and systems.
• Lead team in continuous improvement activities and take control when faced with adversity while incorporating team input.
• Ensure proper maintenance and cleanliness of the department, premises and equipment.
• Measure and communicate team's progress against individual, team and site goals and Key Performance Indicators (KPI's).
• Lead and/or support investigations. Author, approve and/review area quality and safety exceptions and investigation reports. Ensure on-time completion of all corrective action items assigned to area.
• Verify, review and make appropriate changes if needed, to any controlled document pertinent to area of responsibility.
• Identify opportunities to reduce costs, reduce risk and improve service.

Centers of Excellence for Microbiology, Elemental Impurities, and Validation

• Develop policy, create systems, develop strategies and minimize costs while striving for excellence in customer service.
• Establish and maintain positive and mutually rewarding relationships with internal and external customers of the department. T
• Responsible for oversight and management of the training department to include all NEO, CBT and OJT systems in alignment with Mallickrodt policies and procedures.

General

• Budget creation and management for Quality, and Traing Departments (>$15MM).
• Defines requirements of department personnel and works with Human Resources to hire such personnel.
• Acts as subject matter expert and lead with internal and external regulatory inspections and audits of manufacturing sites in the area of Quality Systems, and Training.
• Interfaces with FDA and regulatory agencies outsite the US for events that include but are not limited to: manufacturing site inspections, Field Actions, and Recalls.
• Perform other duties as assigned.

MINIMUM REQUIREMENTS:

Education:

Bachelor's degree in chemistry, microbiology or similar life sciences or technical field such as engineering, mathematics, etc.

Experience:

• Minimum of 15 years of pharmacuetical industry experience in a Quality Assurance and/or Regulatory Affairs function including experience in manufacturing and control of bulk drug substances, and solid dosage form drug products.
• Minimum 5 years managerial experience in a pharmaceutial quality/regulatory affairs environment.

Preferred Skills/Qualifications:

• Previous experience serving as a pharmaceutical manufacturing site leader of a significant quality function (Total Plant population >500 persons, Quality Function >100 persons).
• Exceptional oral and written communication skills. Strong managerial and excellent negotiating skills in order to obtain balanced results from direct and indirect reports.
• Knowledge of FDA and International regulations and guidances in the area of Quality Systems for pharmaceutical products and medical devices.
• Experience interacting with regulatory agencies such as the FDA and EU regulatory bodies as an inspection host.
• Strong patient and customer focus.

Skills/Competencies:

• Strong writing skills to effectively communicate technical/clinical information to others.
• Ability to use various software programs (Word, Excel, Power Point, Access) and a willingness to expand and increase these competencies.
• Superior verbal communication skills including impeccable telephone etiquette.
• Scientific literature searching and evaluation skills.

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

This position reports to the Head of Quality. This position will have frequent communication and working relationships with USA manufacturing plant management and QA/RA personnel.

Contact with regulatory authorities, state, federal and international is common.

WORKING CONDITIONS:

This Position works primarily in an office environment. Ability to sit for long periods of time and lifting of up to 10 pounds may occasionally be required. Will require occasional periods in the manufacturing areas and walking throughout the plants. Manufacturing areas are not climate controlled. During summer months, building exhaust fans provide ventilation but remain warm. When in manufacturing areas, PPE is required to be worn

Approximately 10 to 15% travel (mainly domestic, but some international) will be required for manufacturing site visits and off-site business meetings and professiona training seminars and conference.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.