Sr. Manager, Validations

JOB PURPOSE

This position is responsible for all or multiple segments of the validation function through subordinate supervisors.  Responsible for managing, developing and implementing validation processes to ensure equipment cleaning, equipment, components, process and products meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices. Oversees and reviews validation area processes and procedures, making recommendations for changes and/or improvements.  Position may focus on equipment, process or control system validation or a combination there of.

 

KEY ACCOUNTABILITIES

• Regular and predictable onsite attendance and punctuality.
• Incumbent will schedule, plan and manage validation projects including a new facility planning and construction equipment selections, acquisition, installation and use; facility/system/process improvements, modifications and additions; new product/process material qualifications, computer-based systems and software and cleaning of equipment used in the manufacturing of drug products.
• Select, develop and retain teams.  Define and communicate criteria by which teams and individual success will be measured.  Provide constructive feedback and recognition.  Effectively coach, mentor and motivate others for optimal performance.
• Responsibilities also include oversight for the development, completion, approval, logging and archiving of documentation on Validation Master Plans, and Validation protocols and reports.
• Responsibilities may also include directing or participating in: performing technical failure analysis of processes/product not meeting specifications, investigate/address and reporting on trends to reduce product/process variability.
• Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to product and process validation / manufacturing to ensure compliance in all manufacturing efforts.
• Applies statistical analysis and design of experimental approaches to process development activities where applicable.
• Develops and administers budgets, schedules and performance requirements.  Coordinates activities of personnel in other departments and contractors as well as providing day to day guidance to the Validation staff. Acts as advisor to subordinates to meet schedules and/or resolve technical problems.        
• Participates in developing Divisional procedures and guidelines and developing responses to corporate, regulatory and third-party audits findings.

 

COMMUNICATIONS AND WORKING RELATIONSHIPS

INTERNAL

• Works with all levels of management and Supervision to ensure proper delivery of objectives in a timely manner. The Senior Manager will be interacting with all departments to represent validation compliance, planning and integrity.

EXTERNAL

• Works with auditors (regulatory, corporate, clients) to ensure compliance to Regulatory Standards. Works with vendors for equipment qualification execution, FAT, SAT and to resolve issues with machine, cleaning performance to Regulatory Standards.

 

QUALIFICATIONS

Minimum

• BA or BS in the Life Sciences/Engineering/Math/Chemistry or other job-related discipline.

 

EXPERIENCE

Minimum

• 10 years related experience in validation within a pharmaceutical, biotech or related industry.
• 3 years of project management experience required.

 

SKILLS

• Requires excellent analytical skills with systematic approaches to problem solving.  Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
• Must be able to identify subtle discrepancies in processes or products and have good judgment in determining impact and potential risk.
• Capable of analyzing and solving complex problems through innovative thought and experience, as well as project management tools.
• Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
• Able to manage multiple cross-functional teams simultaneously.
• Must demonstrate effective supervisory/leadership skills.
• Proficient in Microsoft Word and Excel, computer software.
• Sound industry knowledge, project proficiency, and autonomy expected.
• May be considered a Subject Matter Expert (SME) in various disciplines.

 

What We Offer

• Clean climate-controlled working environment
• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program