The QA Supervisor, Quality Systems and Compliance is responsible to lead and inspire a team of quality system professionals, having oversight for maintenance of and cooperation with cross-functional teams to enable them to adhere to the company's regulatory compliance requirements for all internal Quality Systems. This role encompasses the oversight in the areas of internal and client audit programs, supplier and material qualification programs, document control and training across multiple facilities.
DUTIES
- Supervises QA personnel, including organizing and prioritizing group tasks, performing training, performance management, and staff development
- Performs internal and supplier audits to evaluate compliance to standard operating procedures, quality and regulatory standards and is responsible for creating and issuance of audit reports
- Responsible for scheduling and hosting client audits and coordinating audit responses for any deficiencies from internal stakeholders, as well as reviewing all audit responses to assure non-recurrence of deficiencies
- Maintain, trend, analyze and report quality metrics as it relates to internal, supplier and client audits
- Drafting, review and management of supplier quality assurance agreements (QAA's) and non-disclosure agreements
- Provides support during FDA and other regulatory agency inspections and support inspection readiness activities
- Facilitate internal training on GMP and regulatory requirements, processes and procedures as needed
- Writes and revises QA Standard Operating Procedures (SOP), supports continuous improvement initiatives
PROFESSIONAL SKILLS
- Strong people management skills to lead and motivate team members in a creative and effective manner
- Ability to effectively communicate technical concepts to some non-technical audiences
- Strong internal customer service / people skills required
- Excellent professional verbal, written and interpersonal skills is required
- Strong planning and organizational skills and the ability to multitask and meet deadlines is required
- Proficient in Microsoft Office (Word, PowerPoint, Excel, Access) is required
- Demonstrated ability to multi-task in a dynamic environment with changing priorities
- Able to meet challenging timelines, think strategically and tactically, balancing workload changes
EXPERIENCE
- Must possess a working knowledge of FDA (21 CFR 210, 211, 820) and EU regulatory requirements
- Experience implementing or administration of eQMS software system is highly preferred
- Auditing certification is highly preferred (i.e., ASQ, CQA or similar)
EDUCATION
- 5+ years of relevant experience in the pharmaceutical industry, specifically in an aseptic manufacturing environment, and a BS in a science discipline
- 3+ years of relevant experience and a MS
QUALITIES
- Self-motivated with a drive for excellence
- Motivates and inspires others
- Positive attitude and strong interpersonal skills
- Honesty, integrity, respect and courtesy with all colleagues
- Creative and can work with minimal supervision following internal procedures balanced with independent thinking
- Resilient through operational and organizational change
PHYSICAL REQUIREMENTS & MENTAL DEMANDS
- Requires the ability to communicate effectively using speech, vision, hearing and written word
- Requires bending, squatting, climbing, reaching
- Must be able to walk or move or drive between locations
- Must be able to sit or stand for prolonged periods of time
- Requires the ability to lift, carry, push or pull light weights, up to 20 pounds
- Must be able to travel between multiple production facilities
- Ability and willingness to travel at least 15%- 20% of time is required (domestic and/or international)
COMMUNICATIONS & CONTACTS
- Interacts with all departmental staff, external clients and suppliers
MANAGERIAL & SUPERVISORY RESPONSIBILITIES
- Management of direct reports
- Travel expectations - 15-20%
