|職名||Sr Auditing Manager|
|勤務地||Japan - Tokyo|
Senior Auditing Manager - Top Global Mega Pharma
As assigned, independently conduct, participate and lead audits and assessments of contract manufacturers, select raw material suppliers and service providers, group sites that manufacture and distribute finished product and API, as well as Companies Country Office locations that have affiliate quality operations responsibility.
Assess adherence to relevant regulatory GMP guidance documents, Company Quality Standards, Functional and local SOPs and Company expectations.
Assess whether employees are being properly trained for their responsibilities
Assess continued adequacy of the facilities and equipment being used for manufacturing and testing of finished product and APIs
Assess the concepts of cGMPs and compliance with requirements in the quality agreement and/or with Company expectations / standards.
Assess and report weaknesses that could lead to non-compliant manufacturing and/or distribution of products.
Assure that the facility / supplier / contract manufacturer is executing activities (manufacturing, testing, regulatory compliance) per Company Quality agreements / expectations.
Communicate relevant quality, EHS and business information to the facility / supplier / contract manufacturer in an effort to maintain and enhance the relationship between the audited entity and Company.
As assigned, aid the group site or applicable contract manufacturer in preparing for upcoming regulatory inspections
Applies technical knowledge to influence planning/designing cross functional projects
Interprets regulatory and business challenges and best practices to recommend improvements and/or solutions to cGMP or compliance issues at sites
Lead / participate in Company audits at the facility / supplier / contract manufacturer. Responsibilities for this activity include but are not limited to:
Assist in scheduling the audit or schedule the audit
Assist in or lead audit preparation activities
Lead the audit execution, or actively participate in the audit execution as directed by the lead auditor
Assist in or lead the preparation of the audit report
Assist in or lead in the review of auditee’s audit response
Perform audit follow-up activities as required or as directed by group leadership
In appropriate situations, initiate reviews through consultation and agreement with others, including subject matter experts
Maintain the appropriate database with any relevant information pertaining to the facility / supplier / contract manufacturer audit.
Maintain and expand current knowledge of applicable laws, regulations, guidelines, and other pertinent policies, procedures, and standards that could impact the operations at the facility / supplier / contract manufacturer.
Liaise between the facility / supplier / contract manufacturer and the appropriate Company groups, to ensure that any and all pertinent information that could have an impact on the auditee’s or Companies business (e.g., auditee’s regulatory inspection activities or significant changes) are requested, provided and documented.
Conduct and participate in due diligence site assessments as required to assess auditee’s Quality compliance.
Able to collaborate proactively with leadership, site personnel and subject matter experts, to enable a culture of excellence in independent objective audits and effective CAPAs.
Additionally the Senior Manager MSQA:
Can effectively cope with change during an audit
Is able to lead a diverse audit team and effectively interact with personnel of multicultural backgrounds
Can relate to and has the ability to communicate and interact with colleagues at all levels of the organization
Anticipates potential objections and influences others to ensure appropriate outcomes
Knows how the business works by monitoring regulatory audit trends
Actively leads or participates in cross functional teams for significant and complex projects, and contributes towards outcomes that promote innovation and excellence
Must be able to able to assess quality and compliance risks in the field and communicate potential regulatory and/or company non-compliance matters to senior leadership and/or third party vendor management and/or technical staff with assurance
Bachelor’s Degree, preferably in the natural sciences, or equivalent required.
Minimum 10 years progressive, challenging experience in pharmaceutical, biotech industry required (experience to include quality control / assurance, manufacturing, GMP auditing and may include product development) including:
Experienced in operational risk and compliance management, including experience in Quality auditing across a variety of dosage forms (e.g. analytical, API, biologics, aseptic, drug product, medical device) and “audit targets” (suppliers/contractors/facilities).
Must understand a variety of quality/operational systems that support contractor and supplier audits and quality supply chain management
Has a good understanding of relevant regulatory and audit frameworks that apply to the biopharmaceutical operations and In-depth knowledge of cGMP regulations trends and expectations and familiar with other GXP concepts and global regulations (FDA, EU, TGA, PIC/S, etc.) and must be capable of understanding and reacting to business and regulatory trends
Understands GMP requirements (PQSs, local regulations, and regulations where the material / product is marketed), practical understanding of the facility operations and is able to communicate effectively in order to influence desired outcomes
Is qualified in three or more of the technical skill sets, preferably complex ones (analytical, API, biologics, aseptic, drug product, medical device) applicable to the facility audit. (Recognized Auditor certification preferred).
Critically evaluates information from the facility and the team and makes clear recommendations, and is able to propose potential solutions.
Must be adept at managing multiple tasks and changing assignment based on changing priorities. Is willing to proactively propose tasks as needed.
Good organizational skills (audit preparation, audit conduct, audit tracking) and issuance of audit reports aligned with MSQA audit metric targets.
Has the ability to recognize symptoms of problems or situations that require further evaluation, analyze symptoms to determine potential causes, suggest possible corrective actions. Can independently determine necessary input from subject matter experts in order to support these activities.
Ability to work independently and work well in a team as a lead auditor or participant, and an effective communicator to peers, Quality leaders and managers (inside and outside the company).
Actively works to achieve a balanced audit plan, supportive of urgent audit requests and flexible to changes.
Audit reports are written to reflect the required style and content, with findings levelled appropriately, and applying ‘write right’ and ‘right first time’ principals.
Ability to conduct ad hoc Quality assessments (e.g. Data Integrity, due diligence) as required to support business needs.
Ability to lead or participate in significant business related cross functional projects and contribute to innovative outcomes
Must be able to travel domestically and internationally on a frequent basis. (40-50%)
Must be fluent in Japanese. Native speaker is a plus.