Compliance Manager
Company: Just - Evotec Biologics
Location: Redmond
Posted on: January 21, 2023
Job Description:
Just is seeking a highly motivated individual who desires a
significant opportunity to improve worldwide access to
biotherapeutics. We are looking for someone to join a fast paced,
collaborative, and multidisciplinary team as a senior contributor
supporting compliance and auditing activities. You will be
responsible for ensuring maintenance with industry
regulations/expectations as applicable to governing quality
systems. You will be responsible for coordination and execution of
internal and external audits per applicable global procedures. You
will lead cross site efforts/projects in support of compliance
which will help in fostering the achievement of the company's
global mission.As a Manager, you will apply sound technical and
quality knowledge to interpret and apply regulations/requirements
across a broad range of cGMP activities, and provide sound
guidance/direction to GMP functions. You make complex and routine
decisions with minimal guidance from management. You have a solid
understanding of quality systems as they relate to the
manufacturing, testing of API/drug substance starting materials.
You're continually expanding your knowledge of quality
requirements. You will navigate global systems and identify and
manage different levels of risk in support of good quality judgment
against global systems and regulations, including advising the
business on moderately complex quality issues.Responsibilities:
- Responsible for collaborating with the Site Compliance Lead to
support Inspection Readiness activities for client audits and
inspections ensuring a state of readiness.
- Ensures the site organization has an 'Inspection Ready' program
with personnel preparation for hosting/supporting inspections and
inspection follow up; Interact with partner and Health Authority
auditors as the SME and support the audit process.
- Responsible to develop, adhere to and execute against the
internal and external audit schedule to meet procedural
requirements.
- Coordinate end to end audit and inspection readiness
activities.
- Leads the internal and external auditing team and executes
internal and external audits to ensure compliance with current
regulatory expectations, including sound audit preparation, and
execution.
- Monitor and report status of remediation actions resulting from
audit and inspection findings and drive efforts through to
completion
- Contributes to the maintenance of the audit program in
compliance with applicable Just Evotec Biologics Quality Standards,
as well as continuous improvement of the program.
- Ensures ongoing presence within GMP manufacturing and testing
areas to assist Just Evotec Biologics ability to maintain exemplary
compliance.
- Establishes her/himself and the team as SMEs for cGMP related
compliance and acts as a resource to GMP functions as needed.
- Collaborates across the network and industry to identify and
replicate best practices for auditing and to maintain currency with
latest regulatory expectations.
- Implement and maintain the internal audit and client audit
program including planning of audit events and performance of the
internal audit in accordance to the annual schedule
- Monitor, publish and report audit and inspection metrics in
accordance to Quality Management Review requirements.
- Review and analyze Compliance data to look for trends,
opportunities, and advise leadership through metrics.
- Executes moderately complex tasks with minimal coaching.
- Leads and/or participates on special projects, limited duration
teams, and local or global initiatives such as continuous
improvement teams.
- Manage IT tools which supports the Inspection Readiness
activities for audits and health authority inspections.
- Demonstrate a flexibility and agility to fit any future
business needs.QualificationsMust-Have
- Bachelor's Degree with 10+ years of relevant experience within
the pharmaceutical industry OR MS with 8+ years of relevant
experience within the pharmaceutical industry.
- Direct Experience hosting and/or leading Regulatory
Inspections, Client Audits and continuous improvement projects
- Extensive knowledge of global GMP and regulatory requirements
as related to the pharmaceutical drug manufacturing process is
required (Data Integrity, Part 11, etc.).
- Strong evidence of collaborative nature, with strong
interpersonal, organizational, and communications skills are a
must.
- Self-motivated, engaged and able to perform moderately complex
tasks independently.
- Experience with auditing of pharmaceutical manufacturing,
testing, and storage operations.
- Leadership experience required (direct leadership, project
leadership, and/or indirect leadership).Physical/Mental
Requirements
- Ability to gown and enter the manufacturing suite as
needed.
- Mental agility to handle a broad scope of different types of
quality assurance work (i.e., reviewing documentation, conducting
audits and hosting inspections, communicating one on one or with
larger groups). Ability to independently problem-solve and make
recommendations for solutions.
- As this role will represent Just Evotec Biologics to third
parties or regulatory inspectors it is essential that the candidate
has the ability to remain calm under pressure and is able to adjust
and modify their style dependent upon the specific audit
situation.
- This role will be a combination of remote work and onsite
work.The base pay range for this position at commencement of
employment is expected to be $115,000 to $140,000; Base salary
offered may vary depending on individual's skills, experience and
competitive market value. Additional total rewards include
discretionary annual bonus, comprehensive benefits to include
Medical, Dental and Vision, short-term and long-term disability,
company paid basic life insurance, 401k company match, flexible
work, generous paid time off and paid holiday, wellness and
transportation benefits.FR : Dans le cadre de sa politique
Diversit--, Evotec --tudie, -- comp--tences --gales, toutes les
candidatures dont celles des personnes en situation de handicap.ENG
: In the frame of our Diversity policy, Evotec considers, with
equal competences, all applications including people with
disabilities.
Keywords: Just - Evotec Biologics, Redmond , Compliance Manager, Executive , Redmond, Washington
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