Associate Director

Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

Position: Associate Director

Location: Foster City CA 94404

Duration: 12 Months

Job Type: Contract

Work Type: Onsite

Job Description:

Primary Responsibilities

• Works closely with Quality & Medical Governance staff and Business Functions to provide expert input management of issues and support for continuous improvement.

• Handle multiple projects and ensure overall and timely completion of tasks.

• Collaborate and provide input into internal and external audit programs which support GxP compliance.

• Supports the proactive identification and management of GxP risks

• Support deviation identification, reporting, and CAPA development

• Supervise, develop, train and manage internal staff as required.

• Undertakes effective compliance reporting to Quality and Medical Governance senior management and cross functional leadership

• Leads assigned quality forums and provides input to other quality forums as required.
  Leads intra/inter-departmental teams and/or projects that support preparing the Company for minor changes in regulations and continuous improvement of the Quality Management System. Builds positive support and acts as role model for change.

• Contributes to establishing and reviewing quality standards and procedures and represents Quality and Medical Governance in cross functional Working Groups as required

• May lead/support management of regulatory inspection activities such as readiness preparation, inspection host/co-host, and/or provision of input into responses to inspection reports.

• Leads efforts to increase the commitment to quality in individuals and a culture of quality within the organisation.

Essential Functions:

• Works closely with Quality & Medical Governance staff and Business Functions to provide expert input management of issues and support for continuous improvement

• Collaborate and provide input into internal and external audit programs which support GxP compliance.

• Supports the proactive identification and management of GxP risks

• Support deviation identification, reporting, and CAPA development

• Undertakes effective compliance reporting to Quality and Medical Governance senior management and cross functional leadership

• Leads Medical Affairs quality governance forum and provides input to other quality forums as required.

• Monitors changes in industry/regulatory environment that would necessitate future changes and proactively initiates discussions to prepare the company to respond to such changes.

• May lead/support management of regulatory inspection activities such as readiness preparation, inspection host/co-host, and/or provision of input into responses to inspection reports.

• Contributes to establishing and reviewing quality standards and procedures and represents Quality and Medical Governance in cross functional Working Groups as required.
  Helps support a culture of quality within the organisation.

• Handle multiple projects and consider a number of factors in planning and prioritizing work to meet tight timelines.

• Builds positive support for position outside of formal meetings.

• Determines most efficient and appropriate method of communication in a variety of situations.

• Understands impact of decisions and actions on business and consults with appropriate colleagues and management.

• Promotes and maintains productive working relationships.

• Addresses sensitive issues in an objective manner.

Knowledge, Experience & Skills:

Essential:

• A BS or MS degree (or international equivalent)

• 10-12+ years of relevant experience and a Bachelor's degree in a relevant discipline.

• 10+ years of relevant experience and a Master's degree, or equivalent, in a relevant discipline.

• 8+ years of relevant experience and a PhD or equivalent

• Considerable relevant GxP experience working in a pharmaceutical quality control, quality assurance or compliance environment.

• Must have a highly developed knowledge of regulatory requirements for assigned area.

• Is recognized as a knowledgeable resource within the department and from other departments on a range of topics and someone whose opinion is sought as a regulatory resource.

• Understands current global and regional trends in regulatory compliance and has the ability to assess the impact of these requirements to the business.

• Strong verbal and written communication skills and interpersonal skills.

• Proficient in Microsoft Office suite. Experience with audit management/CAPA management programs strongly preferred.

• Excellent organization skills and project management.

• Able to work equally well as part of a team or independently

• Ability to travel approximately 25% required.

Intake Call:

• The specific area of responsibility for the contractor position is to be a Single Point of Contact (PoC) within Quality & Medical Governance for functions undertaking GxP activities involving non-interventional (NIS)/observational research managed by Clinical Operations Late Phase, and potentially also assisting in the support of NIS managed by Clinical Data Sciences Real World Evidence (CDS RWE), Value & Access Health Economics & Outcomes Research (HEOR) and/or Medical Affairs.

• The role includes, but is not limited to, fostering a close, proactive collaboration with stakeholders to enable engagement on quality issues and process improvements, contributing to establishment and review of quality standards and procedures, representing Quality and Medical Governance in cross functional Working Groups, supporting the proactive identification and management of GxP risks, supporting deviation identification, reporting, and CAPA development, leading/participating in quality governance fora, monitoring changes in industry/regulatory environment, etc.

• Additional responsibilities include, but are not limited to, collaborating and providing input into internal and external audit programs which support GxP compliance, leading/supporting management of regulatory inspection activities, etc.

• For this role, the individual should have a strong GCP compliance background, which could include conducting GCP audits (although they will not be conducting audits in this position), because although NIS are not covered by GCP regulations, they are conducted "in the spirit of GCP", entailing many of the GCP-required documentation and activities (protocol, ICF, ethics committee approval, etc.).

• A real plus would be someone who has actual experience in NIS/observational studies, using both primary and secondary data collection.

TekWissen Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.