Sr. Manager GXP Compliance - South San Francisco, CA | Biospace
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Sr. Manager GXP Compliance

Theravance Biopharma, Inc.

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Location:
South San Francisco, CA
Posted Date:
9/1/2017
Position Type:
Full time
Job Code:
777962
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Analytical Chemistry, CMC, Compliance, Information Systems, Manager, Manufacturing/Production, Microbiology, Operations, QA, QC, Quality, Quality Assurance, Quality Control, Validation,

Job Description

JOB PURPOSE


The position will play an essential role in the company’s GXP Regulatory Compliance program; to ensure adherence to applicable domestic and international regulations, Theravance’s internal quality system, and California Department of Public Health Food and Drug Branch requirements.

The incumbent will be primarily responsibility for the day to day planning, execution, and follow up regarding overall internal and external compliance evaluations; regulatory enforcement intelligence, and tracking various commitments to closure.

DUTIES AND RESPONSIBILITIES

The incumbent is responsible for establishing policies, procedures and systems to support development activities in compliance to Theravance quality standards and applicable cGMP and GVP requirements.  These responsibilities include:

•   Actively participate in the review and assessment of internal GxP and Quality systems and provide input to Technical Operations, Clinical Safety and Pharmacovigilance, and various support functions to ensure compliance with applicable regulatory requirements

•   Assist in the development and maintenance of internal and external audit schedules; assist in developing tools for auditing, assessing, measuring, tracking and reporting of quality and regulatory compliance; and actively plan, conduct and document audits

•   Plan and conduct debriefings and presentations of audit findings to Theravance internal customers and management

•   Responsible for follow-up with contract service providers and internal GXP departments/functions to rectify audit deficiencies, as necessary

•   Responsible for compiling, analyzing and reporting audit program metrics used for process improvements to Theravance management

•   Research and provide regulatory enforcement intelligence on to internal clients and Quality team members

•   Serve as a point of contact for contract service providers to receive and disseminate notice of inspections, inspectional findings, and resulting responses

•   Assist / support the Clinical QA group and Operations QA group in providing expert GxP advice to GxP operational departments based on analysis and interpretation of updates to GxP regulations to assure best practices

•   Report significant and/or serious ongoing quality deficiencies to QA and GxP area Management

•   Develop, coordinate, conduct and/or supervise targeted training to GXP department personnel and others at Theravance as required

•   Assist with the organization, preparation, coordination, and documentation of regulatory inspections of investigator sites, GxP contract service providers and/or Theravance GxP departments/functions

•   Supervising, mentoring and developing audit consultants

•   Other projects as directed by Quality/Regulatory Management

Requirements

QUALIFICATIONS

•   B.S. or advanced degree in chemistry, biology or related science with minimum 7 years’ experience in the pharmaceutical / biopharmaceutical Quality.

•   Minimum 5 years’ experience managing Compliance in Quality

•   Minimum 3 years’ experience auditing (certification is a plus)

•   Ability to deal with ambiguity, creative approach to problem solving and ability to define a clear path forward with emphasis on keeping things simple.

•   Ability to work effectively with various technical groups and a strong working knowledge in one or more of the following disciplines: API or drug product manufacturing, pharmaceutical sciences, analytical development / QC labs, equipment/facilities/computer validation principles and/or Pharmacovigilance requirements

•   Solid understanding of U.S. regulations and preference for understanding E.U. regulations.  Other international regulations and standards are beneficial.

•   International auditing experience is preferred

•   Strong oral, written, advocacy and interpersonal skills.

•   Customarily and regularly exercises discretion and independent, sound judgment in the performance of the duties described above

•   Travel will be required approximately 25% of the time, some international

DIRECT REPORTS

Potentially Contract Auditors

PHYSICAL REQUIREMENTS

The incumbent will spend a considerable amount of time looking at a computer monitor and typing.  The employee will frequently be required to talk and have good listening skills. The employee is occasionally required to stand, walk, use hands to touch, handle, or feel, reach with hands and arms, stoop or crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

WORKING CONDITIONS

This position will have normal office working conditions.  When travelling, the incumbent will be required to sit and stand for long periods of time.  In addition, the incumbent will need to be able to visit manufacturing and testing and research facilities, don gowning as needed and be physically able to enter facilities who perform services on behalf of Theravance.

Key accomplishments for someone in this position would be to demonstrate the ability to perform the above listed responsibilities with minimal direct supervision. Demonstration of leadership and initiative are critical to achieving the manager's goals. Additionally, the incumbent must be able to demonstrate decision and negotiating skills both externally and internally to ensure an optimal level of compliance is maintained at Theravance.