Overview

This position is responsible for organizing, planning and managing the personnel, systems and resources critical to the daily operation of the department(s). The Manager works cross functionally to ensure processes and procedures in place align with regulatory requirements and are supported.

Qualifications

Experience / Education

• Ten (10) years experience in a cGMP pharmaceutical environment
• Bachelor’s Degree or equivalent in the Sciences
• Must have 3 or more years of experience managing personnel

Knowledge / Skills / Abilities:

• Ability to use judgment, clear problem-solving and decision-making skills
• Ability to work under limited supervision and to handle complex problems
• Excellent organizational and interpersonal skills. Ability to communicate effectively with all levels of the organization
• Thorough working knowledge of Regulatory Compliance, Quality System Management and Quality Assurance principles and practices
• Proficient in Oral & Written communication skills
• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)

Physical Requirements:

• Must be able to work in a Lab and manufacturing setting
• Must be able to wear appropriate PPE
• Must be able to work in environment with minimal noise levels
• Ability to stand for long periods of time
• Clarity of vision
• Ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions
• Inside working conditions

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

Responsibilities

Essential Job Functions:

• Responsible for the oversight of the Quality Assurance (QA) team, who performs audits (critical phase and manufacturing) and applicable document reviews (Validation/Qualification, batch records (cGMP), Certificates of Analysis (GMP), Certificates of Testing (GMP) and/or other necessary documentation, as appropriate to the defined Quality Role within the applicable regulation(s)).
• Lead/Support internal, client, regulatory and accreditation audits and inspections; respond to inspection findings in a satisfactory and timely manner.
• Lead and/or participate on cross-functional teams and projects representing quality in positive and compliant manner. Work and interact in a collaborative manner at all levels of the organization.
• Support from the QA perspective validation / qualification activities for the facility, utilities and equipment.
• Ensure systems in place maintain compliance to current Good Manufacturing Practices (cGMP), and/or applicable standards set forth.
• Monitor and maintain procedures for adherence to regulatory compliance requirements. Focus on driving continuous compliance and quality improvements.
• Develop, implement and approve policies and procedures.
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and STA Pharmaceutical USA Policies and Standard Operating Procedures.
• Review, approve, and perform investigations. Provide guidance for non-compliance situations using creative problem solving skills.
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Create/monitor/report team metrics.
• Conduct employee reviews and respond to employee issues.
• Ensure staff are fully-trained; providing adequate leadership, mentoring, and support.
• Participate/lead continuous improvement initiatives both within QA and cross functionally.
• Ability to work in a team environment and independently as required.
• Contribute to the overall operations and to the achievement of department and site goals.
• Assist with monitoring and managing departmental expenses, e.g., headcount, overtime, etc.
• Other duties as assigned.