Director Quality Control

Job Overview :

Applying for this role is straight forward Scroll down and click on Apply to be considered for this position.

Overall responsibility for the Quality Control function daily.

Responsibilities :

• Direct and supervise personnel and activities within the Quality Control Laboratory.
• Develop strategic plans for the Department and personnel.
• Execute assignments as directed by the Head of Quality Control with no supervision.
• Independently manage all laboratory activities for assigned functions and projects, including developing timelines, daily (and longer-term) work plans, assignments, and milestones for their direct reports.
• Manage, motivate, develop, and coach members of the QC Laboratory to achieve identified objectives, maximize their potential, and continuously improve their individual effectiveness in meeting business needs.
• In support of other Departments (e.g., QA, RA), execute investigations, deficiency-letter responses, and CAPA-related activities.
• Interface with Analytical R&D, Quality Assurance, Business Development, and Manufacturing Departments for coordination of project activities.
• Support formulation development and transfer activities for assigned projects.
• Investigate method performance, reliability, and improvement issues, and evaluate proposed changes to compendial or in-house methods.
• Prepare and review technical documents, including validation protocols and reports, reference standard qualification reports, analytical test procedures, Certificates of Analysis, technical reports, change controls, and investigations and deficiency reports.
• Provide training, technical expertise, and support to the laboratory staff.
• Standardize processes throughout the laboratory and enforce compliance to cGMPs and SOPs.
• Ensure that the analytical procedures developed, reviewed, or established in the laboratory conform to current and appropriate scientific and regulatory standards suitable for their intended purpose.
• Develop and implement procedures, systems, and training activities to develop an appropriate level of scientific expertise within the laboratory to ensure the successful execution of projects.
• Work to current pharmaceutical-industry technical standards and maintain compliance with cGMPs.
• Audit and review laboratory data generated by their groups.
• Recommend the need for new equipment to serve expanding operational and regulatory requirements.
• Ensure that specific objectives and goals of the department are met.
• Oversee and ensure that all laboratory equipment qualifications, calibrations, and preventative maintenance programs are maintained.
• Collaborate with colleagues in Research & Development, Regulatory Affairs, Quality Assurance, and external partners and vendors or contractors to achieve project goals.
• Perform other duties as assigned.

Qualifications :

• Bachelor’s degree, or equivalent combination of education, training, and professional experience that provides the individual with the required knowledge, skills, and abilities.
• 10+ years of experience in analytical, organic, or pharmaceutical chemistry within the discipline of analytical chemistry and quality control in the pharmaceutical industry.
• Current understanding of state-of-the-art analytical instrumentation and equipment.
• Familiarity with the operation and maintenance of various analytical equipment and instruments used in the laboratory.
• Strong problem-solving ability; leads investigations and recommends corrective actions.
• Ability to mentor and provide best practices to new technicians.
• Experience in successfully managing complex technical issues using structured analysis and methodology and articulating clear and concise direction to other operations staff.
• Strong experience with project and people management.
• Able to administer personnel performance evaluations.
• Demonstrated ability to write and understand technical information and produce detailed reports.
• Good leadership skills and the ability to establish and maintain good working relationships with other departments, including vendors, colleagues, and subordinates.
• Technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Ability to analyze data and information and assess and resolve complex problems / issues as required.
• Ability to comprehend and follow all applicable SOPs.
• Knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
• Solid understanding of current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
• Ability to portray the appropriate level of integrity and professionalism.
• Ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
• Ability to complete tasks accurately and according to established and shifting timelines.
• Ability to make quality scheduling, resource allocation, and priorities decisions.
• Energetic, execution-focused, self-motivated, and organized individual accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results-oriented and efficient.
• Creative and open-minded, fostering an environment where sharing of ideas is encouraged.
• Ability to work closely with a diverse customer and employee base (internally and externally).
• Ability to work well in a cross-functional team environment.
• Fluency in English and legible handwriting.

Physical Demands :

• Ability to travel between and within facilities to visit staff, operations, and projects as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).

J-18808-Ljbffr