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Endo · 2 months ago

Sr Dir Quality

St Louis, MO

Full-time

Onsite

Director/Executive

15+ years exp

Endo is dedicated to developing and delivering life-enhancing products and is seeking a Senior Director of Quality. This role is responsible for overseeing all Quality functions at the St. Louis Plant, ensuring cGMP compliance, and leading quality assurance and control teams to maintain high product quality standards.

Pharmaceuticals

Comp. & Benefits

Responsibilities

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

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

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

Responsible for oversight and management of the training department to include all NEO, CBT and OJT systems in alignment with Mallickrodt policies and procedures

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

Qualification

CGMP complianceQuality Systems managementRegulatory Affairs experiencePharmaceutical industry experienceMicrobiology expertiseElemental Impurities knowledgeValidation processesTraining managementData analysisSoftware proficiencyLeadership skillsCommunication skillsTeam managementCustomer focus

Required

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

Minimum of 15 years of pharmaceutical 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 pharmaceutical quality/regulatory affairs environment

Preferred

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

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