- Direction and oversight for Internal and External audit program, including standards, and routine reporting of progress to plan
- Direction and oversight for the GXP Contract Organization Qualification Program
- Develop metrics and reporting systems for Compliance risk identification and remediation
- Perform training and education internally in global compliance standards with particular emphasis on US, EU and Japan
- Support Coherus and Contract Organization Inspection Readiness
- Develop and communicate corporate compliance policies and standards for GMP operations and partner with peers in clinical operations to support the development and maintenance of similar documents for GVP, GLP, and GCP operations
- Conducting ongoing intelligence surveillance and communicating industry trends and enforcement activities
- Support In-License Due Diligence Compliance Assessments and Audits
- Report current audit metrics at quarterly QMR
- Ability to travel domestically and internationally up to 15%
- 10-15 years or greater experience in Biotechnology quality and compliance roles.
- Strong knowledge of global GxP expectations and ICH requirements
- Experience in authorship or review of CMC and/or clinical regulatory submissions.
- Experience in Phase III drug development GxP environment and commercial operations.
- Excellent collaboration skills.
- Work independently
- Comfortable working in a fast paced and highly expert environment.
- Excellent communication skills, and comfortable assuming leadership within teams and with external CMO's, CTL's, and CRO's.
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Director, Compliance - Redwood City, United States - Coherus Biosciences
Description
Title:
Director, Compliance
Reports To:
Head of Quality
Location:
Redwood City, California
Classification:
Exempt
Overview:
Principle Responsibilities and Duties:
This position is responsible for establishing and implementing global compliance systems for operations within the Coherus manufacturing operations network.
GxP Compliance is accountable for establishing procedures and processes for inspection readiness and the surveillance of GxP compliance at Coherus, supporting awareness of compliance requirements through surveillance of industry requirements, and to support due diligence activities.
Ensure policies and procedures are in place to that support the reporting and review of quality metrics and systems, vendor qualification and audit program, risk identification and reporting.
Ensure that systems and records are compliant with global regulatory requirements.Specific duties:
Experience, Education, Training, Traits:
Bachelors' degree in Chemical or Life Sciences. Advanced degree preferred
Experience and interpersonal skills:
While performing the duties of this job, the employee may be required to perform lifting tasks of up to 10 pounds for short durations.
Safety
Coherus is committed to the health and safety of our employees.
We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.
The Base Salary Range for this position is $190,000 - $240,000 Coherus considers various factors, including professional background and work experience, when determining base pay.
Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.
Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date.
This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote.
If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
We are currently not accepting any unsolicited resumes from recruiters or employment agencies.
