Sr. Manager of QA(Direct Hire)
Andover, MA or St. Louis, MO (hybrid)
Description for Sr. Manager of QA:
As a Sr. Manager within the Medical Device Quality Assurance Development organization, you will work with the product development teams focusing on medical devices and medical device combination products. You will utilize your knowledge and skills to provide guidance to operational teams and project teams related to design controls (21 CFR 820), risk management (ISO 14971), risk assessments, internal/external audits, Corrective and Preventative Action (CAPA), and other applicable regulatory requirements for the medical device or the device constituent of combination products. You will function as a quality compliance resource and subject matter expert for the company. You will work with the development teams and other organizations to advance new concepts and methodologies. You will take a leadership role to facilitate agreements between different teams, vendors, and organizations. The Sr Manager will be an advocate for quality across Pfizer and will collaborate with other functional teams and design centers reviewing design control deliverables to ensure the developed products are safe and effective.
Responsibilities forSr. Manager of QA:
- Develops and maintains effective working relationships with sites, internal employees, and individuals outside the company including senior leadership, corporate personnel, suppliers, quality and/or regulatory associations and agencies.
- Monitor changes to global regulations and ensure policies and procedures reflect applicable changes, implements quality system best practices, and communicates company-wide policies on quality system effectively.
- Responsible for ensuring Quality Management System execution, and continuous improvement of the same.
- MDCP Quality Assurance oversight of facility, utilities, equipment, computer system validations and change controls. Support Management Review & Quality Councils as required.
- Routinely provides guidance and interpretation of GMPs within PharmSci and with external partners.
- Manages risk for a broader range of issues based on experience.
- Identifies, leads development of, and participates in implementation of new processes/programs for quality improvement initiatives.
- Monitors regulatory and industry environment, interprets information, benchmarks with others, and shares knowledge.
- Advise customers on complex issues within their line function.
- Able to apply new concepts to many applications or work processes.
- Execute assignments independently, complete complex assignments with little coaching and interface with management as needed.
- • Expert in quality investigation techniques and leads complex quality investigations and develops QA decisions. Actively contributes to PSQRT/AQRT.
- Reviews and approves all lifecycle documentation including complex deliverables (multiple systems and devices).
- Has practical understanding of how internal SOPs pertaining to supported line functions are being interpreted locally.
- Proactively seeks global alignment / interpretation in application of policy / procedure.
- Has technical and quality knowledge on later phase product life cycle strategies (e.g. process validation, ICH stability, etc.). Leads and advises as needed.
- Provides innovative/unique metrics analysis and reporting developing actions for key stakeholders.
- Creates, develops, and delivers training courses.
- Performs review of training effectiveness, identifies trends, and develops actions to remediate compliance issues as required.
- Serves as quality lead on due diligence assessments and participates in external audits.
- Maintains a broad understanding of the business and has a positive impact on global work streams.
- Evaluates highly complex quality issues on projects or with vendors and provides suggested issue resolutions.
- Recognized as a coach, mentor, and technical expert
- Participates as an external influencer at conferences or standard committees
Requirements for Sr. Quality Assurance Associate:
- Bachelor’s Degree or equivalent in a scientific/engineering discipline.
- Broad technical knowledge related to the design/operation of medical device or drug combination product platforms, design controls, risk management, 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.
- 7+ years’ experience of working in a Quality Assurance, GMP manufacturing or Medical Device role.
- Extensive knowledge of cGMPs with a broad understanding of scientific principles associated with product development.
- Experience interacting with FDA investigators and other regulatory agencies audits.
- Knowledge and application of device root cause analysis methodology and device CAPA requirements.
- Experience in change management (pre and post launch) of either medical devices or medical device combination products.
- Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues.