Associate Director, Quality

  • location: Cambridge, MA
  • type: Contract
  • salary: $112.85 - $132.77 per hour
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job description

Associate Director, Quality

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!

location: Cambridge, Massachusetts
job type: Contract
salary: $112.85 - 132.77 per hour
work hours: 9 to 5
education: Bachelors
Job Responsibilities

- Provide professional expertise and strong leadership in applicable guidance and regulations, proactively identifying potential areas of non-compliance and risk for assigned areas.

- Execute Internal Supplier Audit strategy at the direction of the Head of Internal & Supplier Audits

- Serve as a QA & Compliance Liaison for Preferred Providers Governance Councils or internal committees, as assigned

- Provide Compliance & Management Support for identified issues arising with supported R&D Business areas, and for other QA & Compliance project initiatives

- Provide support for QA & Compliance Regulatory Agency Inspections

% of Time Job Function and Description

30-50 Audit Coordination

- Liaise and network with internal and external business partners to implement ISA strategy

- Lead the planning, execution and close out of assigned ISA audits

- Lead ISA driven CAPAs, effectiveness checks, and issue escalation, as assigned

- Designated auditor/co-auditor for assigned ISA audits

- Lead ISA facilitated meetings.

- Participate in QA&C project initiatives (System Development and COE driven)

10-30 QA&C Liaison for Preferred Provider(s)

- Liaise and network with internal and external business partners to provide guidance and support pertaining to compliance/quality oversight initiatives

- Prepare and lead or support governance council meetings

- Facilitate issue escalation and oversight of remediation as appropriate

- Manage preferred provider partnership as assigned

15-30 Internal Supplier & Audits and QA & Compliance Support

- Liaise and network with internal and external business partners to implement ISA and QA&C initiatives

- Lead and/or support the planning, execution and close out of assigned ISA and QA&C initiatives

- Provide compliance guidance and support for R&D as appropriate

- Provide support to management as requested

5-15 Regulatory Agency Support

- Support, as needed, the preparation, conduct follow-up/responding, and lessons learned to GXP inspections

- Bachelor's degree in a life science or equivalent experience; Graduate degree in a scientific discipline or program management a plus

- Minimum of 8 years' of pharmaceutical experience, including international experience

- Ideal candidate will have broad experience in product development, regulatory compliance, supplier management, GxP auditing and at least 3 years of direct or matrix management experience.

Key Skills, Abilities, and Competencies

Extensive knowledge and/or awareness of local and international regulations. Maintains awareness of newly published regulations.

- Strong understanding of the: drug development processes, clinical development operations, vendor outsourcing and procurement processes, regulatory affairs, GXP and internal process auditing

- Collaborative team player who has the ability to think and act quickly and identify creative solutions to complex problems

- Robust technical writing skills. Ability to write briefing documents, quality positions, audit reports and SOPs.

- Strong attention to detail with the ability to articulate quality related risks and potential impact.

- Leadership skills, and ability to inspire colleagues

- Ability to take a big-picture approach to decision-making while taking account of the broad interests of Shire.

- Strong project management and decision-making skills

- A self-starter, who motivates, has tact and diplomacy and is able to define and prioritize tasks within a project

- Excellent communication and interpersonal skills.

- Demonstrates ability to manage global staff/activities

- Ability to foster and balance a culture of compliance within a culture of innovation

- Strategic thinking

- Ability to influence without authority, in a matrix environment

- Proficient knowledge of MS Word, Excel, PowerPoint & Outlook; working knowledge of Access, Trackwise a plus.

Complexity and Problem Solving

- Exerts influence in the development of overall objectives and long-range goals of the organization.

- Acts as an advisor to meet schedules or resolve technical or operational problems

- Directly participates in establishing and administering centralized functional projects

- Works on complex problems requiring analysis of situations or data and in-depth analysis of factors

- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Internal and External Contacts

- Interacts across R&D QA & Compliance and R&D Business Partners

Other Job Requirements

- Domestic and international travel may be required per business need.

- Must have a global mindset.

skills: Quality control, Quality Assurance, CAPA
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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