Director, SLS Laboratory Services

Position Summary :

Director, SLS Laboratory Services i provides leadership, direction, and coordinates all Quality Control Laboratory activities in accordance with the Group's procedures, policies, goals, and objectives. As the Group continues to grow, the Director, SLS Laboratory Services will build and lead a highly performing team of quality professionals to meet all current and future needs of the Group and its clients. The ideal candidate should be able to communicate at all levels of the organization and be highly motivated and self-driven.

Essential Duties & Responsibilities :

Specific responsibilities include, but are not limited to :

• Assist Vice President of Global Quality in the development and implementation of the Quality Control Laboratory and site-specific Quality Management Systems (QMS) to meet cGMP requirements including SOPs, client-specific procedures, and safety training programs.
• Client Facing role working with clients to define Scope of Work and stability study models.
• Oversee the Quality Control Laboratory in regard to human resources including interviewing and selection, organizational development, mentoring, coaching, counseling, and employee discipline, as required.
• This position will manage Quality Control Department laboratory personnel to include :
• Managing and prioritizing workloads and projects to ensure effective and efficient completion of Quality Department objectives.
• Developing and delivering Quality Department personnel performance evaluations.
• Maintain appropriate work / life balance for all members of the department.
• Actively engaging in laboratory Quality and Analytical activities.
• Collaboratively working with Senior Management to establish and monitor key performance indicators (KPIs) for Quality personnel.
• Ensuring the Quality Department maintains a perpetual inspection-ready state.
• Ensure all Group employees and on-site service vendors are trained in (as applicable) cGMP, Group SOPs, policies, Client-specific procedures, and safety programs.
• Oversee and direct the implementation and operation of the Quality Control laboratory activities providing bulk sampling, stability assessments, and material evaluations.
• Ensure that all Client products are evaluated in compliance with QMS, Quality Technical Agreements, cGMP, and applicable laws and regulations.
• Responsible for oversight and management Quality Control Laboratory functions such as Laboratory Investigation upon generation of out of specification results; initiate, manage and / or assist in investigation of process deviation or non-conformance, and lead internal audits of Quality Control Laboratory operations.
• Responsible for management of laboratory equipment including commissioning, qualification, calibration, and routine preventative maintenance.
• Assure metrics, goals, and priorities are implemented within the Quality Control department.
• Participate in and provide support for on-site regulatory for laboratory operations including Client and third-party audits of this area.
• Maintain a working knowledge of applicable laws, regulations, and cGMP / GLP requirements.
• Direct initiatives that accomplish continuous improvement, cost effectiveness, new capabilities, and enhanced efficiencies of laboratory operations while maintaining compliance of processes and procedures.
• Communicate to the Vice President of Quality any critical cGMP and / or non-compliance issues in a timely manner.
• Be a contributing member of the leadership team and engage in business decision making from a Quality perspective.
• Facilitate interactions between QC Laboratory, Quality Assurance, Operations, and Business Development teams in order to help set and meet Clients' quality requirements while maintaining compliance.
• Other duties and responsibilities as assigned.

Qualifications :

Education and / or Experience :

Computer Skills

To perform this job successfully, an individual should have proficient knowledge of Microsoft Office 365 Suite, ERP System, validated Warehouse Management System (WMS), and Internet browser software.

Language Skills

Ability to read and interpret documents such as federal regulations and FDA industry guidance documents, safety rules and regulations, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of an organization.

Mathematical Skills

Ability to work with mathematical concepts for data analysis such as probability, statistical inference, variance etc., and fundamentals of plane and solid geometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to stand; walk; use hands to handle or feel; and talk or hear. The employee is frequently required to reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit and taste or smell. The employee must regularly lift and / or move up to 10 pounds, frequently lift and / or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly exposed to moving mechanical parts. The employee could be exposed to wet and / or humid conditions; extreme cold; risk of electrical shock and highly flammable materials. The employee could be exposed to high, precarious places; fumes or airborne particles; toxic or caustic chemicals; outside weather conditions; extreme heat and vibration.

Other Skills and Abilities