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Sr Manager Quality Compliance

Role: Sr. Manager Quality Compliance

Duration: 6 Months (with extensions)

Location: Cambridge, MA

Our client is seeking a Sr Manager of Quality Compliance to join thier team on a long term contract. This role is onsite at their Cambridge

POSITION OBJECTIVES:

  • Responsible for creating and implementing programs and compliance strategies for the O&B GMSGQ business unit. this position ensures that these programs meet all FDA and Global affiliate GMP as well as other Global regulatory agency requirements for the markets client manages, including but not limited to US, Japan, UK, Canada and ROW.
  • This position also leads key compliance initiatives, both locally and globally.
  • In addition, this position interacts with Quality Assurance, Regulatory CMC, Supply Operations, Technical Operations, Development functions, LOCs, domestic and international Contract Manufacturing Organizations (CMOs), and regulatory agencies, including but not limited to, FDA, PMDA, MHRA, EMA, ANVISA, and Health Canada.
  • This position also leads key compliance initiatives, both locally and globally.
  • Makes decisions on behalf of the company on the acceptability of compliance ongoing activities.
  • Serves as an expert in current and emerging regulatory requirements and industry best practices.
  • Directs continuous improvement to ensure programs remain compliant with FDA and other regulatory requirements, Manages the client Inspection Readiness Program.
  • Develops and maintains a broad network of relationships within the local and global environment.
  • Represents the company at corporate and regional meetings and, as necessary, with Regulatory Agencies, industry groups and business partners
  • Advises project teams on compliance strategies to ensure cGMP and company expectations are met.
  • Ensures the establishment of remediation plans if needed to improve compliance standing.
  • Leads due diligence activities to ensure risk based approaches are used and approves operations as part of self-assessment programs,
  • Leads the Quality Council Program for the client and Regional Councils which assess compliance standing and risks associated to Quality Systems health to ensure any negative trends are properly communicated, discussed, addressed and effectiveness of actions taken monitored to assure good standing of our quality systems.
  • Promote risk awareness and proactive remediation to drive compliance results.

POSITION ACCOUNTABILITIES:

  • Manage staff responsible for Quality Compliance programs and compliance interactions with vendors, to assure timely and compliant operations.
  • Makes recommendations regarding long-range resource planning, budgeting and restructuring to meet business needs,
  • Creates a clear vision for the quality compliance area to assure product and process GMP compliance, ensures all internal annual self-assessments requirements are met and compliance is maintained while minimizing risk and cost impact
  • Establishes strategic direction for O&B GMSGQ client compliance programs responsible for ensuring they address regulatory requirements and compliance vulnerabilities.
  • Directs the implementation of programs across internal functions.
  • Leads Supplier Quality Program, which assess risks for CMO facilities and Outside Testing Labs to our products and supply chain to ensure GMP non-conforming operations are appropriately addressed including system correction or improvement of operations to minimize future risks for commercial manufacturing
  • Represent the company at FDA or other regulatory inspections of client, or contract manufacturing organizations and contract laboratories associated with the commercial product Leads and manages audits or due diligence efforts to advance business and compliance objectives supply chain.
  • Independently manage personnel development, ongoing quality conversations and performance issues with minimal guidance.
  • Proactively looks for ways to challenge specialists and create career opportunities and professional development to enhance job satisfaction and improve the department.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • BA/BS with 10+ years Quality experience in the pharmaceutical/biotech industry or Master's Degree with 8+ years Quality experience in the pharmaceutical/biotech industry.
  • Requires use of Quality Risk Management tools
  • Supports the Director with: APQR Management program - carry out the APQRs, NTM, QAMs, MBRs, MACs Market Action Programs
  • Proven management experience with multiple reports.
  • Good presentation skills and able to lead discussions at all levels of the organization
  • Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
  • Ability to handle multiple tasks concurrently, and in a timely fashion.
  • Must be able to communicate effectively with employees, peers and management.
  • Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
  • Good interpersonal skills and be able to work effectively and efficiently in a team environment.

Sthree US is acting as an Employment Business in relation to this vacancy.