Quality Assurance Manager
Department: Quality Assurance
Reports to: Executive Director Operations & Technical Services
The Quality Assurance Manager assures consistent quality of production according to medical device and drug regulations by ensuring quality practices are efficient while enforcing current good manufacturing practices (cGMP). The Quality Assurance Manager is a hands-on position and has responsibility for managing the Quality Assurance staff, maintaining Anika’s established quality systems, and resolving concerns that are scientific and technical in nature.
Strategic Focus Areas
- Provide leadership for quality compliance activities, and corporate initiatives
- Optimize resources within assigned areas to maintain compliance standards and cost discipline
- Create a positive image of Anika Therapeutics through communication and interaction with key stakeholders including employees, customers, partners, vendors, and appropriate government and regulatory authorities
Specific Tactical Responsibilities
- Maintains company compliance with Anika’s standard operating procedures and practices according to current regulations in accordance to 21 CFR 820, ISO 13485, ICH, CMDR and MDD.
- Supervises the Quality Assurance staff by recruiting, training, coaching, counseling, disciplining employees, reviewing job descriptions, and recommending compensation based on employee performance consistent with internal Human Resource policies.
- Organizes department activities to consistently meet supply chain and customer service schedules involving release of raw materials/packaging components, completion of batch record review, resolving nonconformities, and providing necessary documentation for product release.
- Assigns department responsibilities to ensure product quality and compliance by holding quarterly metrics meetings, investigating customer complaints, overseeing company training, supervising the internal audit program, and maintaining Anika’s Supplier program.
- Reviews technical documentation involving equipment qualification, process validation, sterilization revalidation, aseptic production, calibration of critical instrumentation, and recertification of clean rooms.
- Performs investigations requiring the identification of root cause involving product impact assessments using a risk based approach involving scientific information, input from subject matter experts, and historical data.
- Owner of Anika’s corrective and preventative action (CAPA) program ensuring effective implementation of corrections in a timely manner that prevent reoccurrence of systemic issues.
- Meets Quality Assurance financial objectives by implementing efficiencies, assisting in the preparing of annual budget, and correcting budgetary variances.
- Supervises the Document Control department involving the timely implementation of document revisions and the archiving of critical documents.
- Quality representative in customer and compliance audits involving the preparation of Quality documentation and the review of requested information with auditors.
- Responsible for other duties and projects as assigned
Assignments are defined by objectives and required outcome. Exercises judgment within defined parameters and policies; expected to propose practice and policy improvements. Job requires maintenance of up to date knowledge of all applicable international regulation and regulatory guidance. Solid understanding of scientific and engineering principles.
Supervises Quality Assurance and Document Control professionals
- Bachelor’s Degree in a technical or scientific discipline or related previous experience
- Demonstrated knowledge of regulated industries including experience with FDA, ISO 13485:2003, cGMPs, QSRs, MDD is required
- Five to seven years of increasingly complex Quality Assurance experience in a commercial medical device company
- Three to five years of experience in a Supervisory or leadership role
Desired Experience, Knowledge, and Skills
- Engineering degree is strongly preferred
- Demonstrated experience building strong partnerships with Operations and Quality Control departments.
- Previous aseptic manufacturing experience
- Demonstrated experience delivering results in a fast paced, hands-on organization requiring high energy
- Ability to work autonomously, effectively manage time and deliver results on time
- Excellent presentation skills, both written and in platform presentation format
We are an Equal Employment Opportunity Employer