Paladin Pharma · 2 months ago
Sr Dir Quality
St Louis, MO
Full-time
Onsite
Director/Executive
15+ years expPaladin Pharma is dedicated to developing and delivering life-enhancing products through focused execution. The Sr. Director, Quality is responsible for overseeing quality functions at the St. Louis Plant, ensuring compliance with cGMP standards and leading quality assurance and control teams to maintain product quality and regulatory standards.
BiotechnologyHealth CarePharmaceutical
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
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
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
Responsible to make fact-based, scientifically sound, quality decisions regarding products manufactured at the St. Louis Plant facility
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
Budget creation and management for Quality, and Training 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 outside the US for events that include but are not limited to: manufacturing site inspections, Field Actions, and Recalls
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
Company
Paladin Pharma
With headquarters in Montréal, Canada, Paladin Pharma is a leading specialty pharmaceutical company focused on acquiring or licensing emerging pharmaceuticals for the Canadian market.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$93.87M2014-02-28Acquired
2011-02-01Post Ipo Equity· $40.52M
2009-06-11Post Ipo Equity· $53.35M
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