MSAT Qualification Lead
Roche, Virginia, MN, United States
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position Principle Roles & Responsibilities / Accountabilities主要职责/责任 Leadership
Strong creative leadership skills according to Visionary, Architect, Coach, and Catalyst (VACC) model and shown ability to build forward -thinking outlook; remove barriers,
Support Roche's mission of advancing and boldly championing diversity, equity, and inclusion
Build and maintain strong partnerships with site leaders to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships
Contribute to a culture of continuous improvement and model lean leadership principles
Contribute to a culture of transparent, high performance, empowerment and innovation culture
Acts as a mentor and coach to less experienced colleagues, providing guidance in mastering complex qualification workflows, troubleshooting technical challenges, and developing skills in MSAT operations
Technical Engineering Project Support and Site Start Up Readiness:
Participate in the design and construction of new facilities, including but not limited to URS review, FAT, SAT, IOPQ, tech transfer and other aspects related to MSAT activities, thereby contributing to project delivery
Technical Expertise & Routine Operation:
General Customer Service: Identify the customers that are the recipient of the service delivered. Utilize tools such as CRM/Helpdesk, SPOC to establish this understanding and document accordingly. Develop effective relationships with key customers in order to understand their business and expectations. Deliver services according to established service level agreements. Response to customers is timely and communication is efficient. Seek feedback from customers and/or stakeholders on performance and ability to meet expectations. Incorporate feedback. Takes accountability to balance customer expectations and value for Roche. Takes ownership for problem resolution and escalates as appropriate
Support Other Colleagues within the team: Support other colleagues within the qualification team as required (such as Time-based Requalification)
Periodic Review Execution: Execute periodic review of GMP equipment, including protocol, and getting approved
Qualification triggered by Change: Execute qualification triggered by change accordingly, include protocol, and getting approved
CSV Execution: Supervise Testing and Execute Testing in CSV
Periodic Assessment: Execute periodic assessment as required
Qualification Planning and Report: Execute qualification plan and report, include protocol, and get approved
Independently finish qualification activities and solve the relative issue, give guidance to the other engineer in the team
Coordinate Qualification Implementation within technical division:
Provide the technical expertise for routine work and for Site Master Plan projects and Site Engineering projects as well. Actively cooperate with other departments, stakeholder to solve problems effectively
Prepare, review and approve specific qualification summary sections of regulatory submissions. Present the qualification program to regulatory authorities during routine and pre-approval inspections. Drive internal audit and regulatory observation responses, in addition to self identifying gaps and corrective actions for qualification deficiencies as required
Ensure timely and accurate qualification data analysis, review, reporting and trending of data in support of make, test, release and other required metrics
Recommend actions to address adverse findings and/or identify cost effective modifications to current processes as applicable
Other tasks assigned by the manager
Education/Qualifications Qualification and Experience 能力与经验
Bachelor’s Degree (Pharmaceutical / Biological is preferred) and above
Job Required Competencies 岗位所需胜任力
5 or more years qualification experience, 8 or more years MSAT/Technical or qualification experience in the injection pharmaceutical industry, MNC Bio-pharma preferred
People management experience is a plus
Prior experience in validation is advantageous
Demonstrated experience in strategic thinking, exceptional customer service skills; highly skilled in negotiations, collaboration, and influencing
Experienced in strategic project of Aseptic Filling facility including design, commissioning & qualification
Strong communications skills including the ability to communicate fluently in English, both verbally and written; holds difficult conversations and works through conflict; checks in with colleagues to ensure comprehension of key points are accurately conveyed
Strong business acumen, communications, and analytical thinking required
Strong interpersonal, leadership, collaboration and conflict resolution skills
Experienced in new facility startup readiness and operation ramp
Strong knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological industry
Experience leading major change initiatives strongly preferred
Project management skills and Leading team capability preferred
Able to think strategically and translate strategies into actionable plans, understands and applies agile ways of working
Knowledge of Quality management
Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Equal Opportunity Statement Roche is an Equal Opportunity Employer.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
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The Position Principle Roles & Responsibilities / Accountabilities主要职责/责任 Leadership
Strong creative leadership skills according to Visionary, Architect, Coach, and Catalyst (VACC) model and shown ability to build forward -thinking outlook; remove barriers,
Support Roche's mission of advancing and boldly championing diversity, equity, and inclusion
Build and maintain strong partnerships with site leaders to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships
Contribute to a culture of continuous improvement and model lean leadership principles
Contribute to a culture of transparent, high performance, empowerment and innovation culture
Acts as a mentor and coach to less experienced colleagues, providing guidance in mastering complex qualification workflows, troubleshooting technical challenges, and developing skills in MSAT operations
Technical Engineering Project Support and Site Start Up Readiness:
Participate in the design and construction of new facilities, including but not limited to URS review, FAT, SAT, IOPQ, tech transfer and other aspects related to MSAT activities, thereby contributing to project delivery
Technical Expertise & Routine Operation:
General Customer Service: Identify the customers that are the recipient of the service delivered. Utilize tools such as CRM/Helpdesk, SPOC to establish this understanding and document accordingly. Develop effective relationships with key customers in order to understand their business and expectations. Deliver services according to established service level agreements. Response to customers is timely and communication is efficient. Seek feedback from customers and/or stakeholders on performance and ability to meet expectations. Incorporate feedback. Takes accountability to balance customer expectations and value for Roche. Takes ownership for problem resolution and escalates as appropriate
Support Other Colleagues within the team: Support other colleagues within the qualification team as required (such as Time-based Requalification)
Periodic Review Execution: Execute periodic review of GMP equipment, including protocol, and getting approved
Qualification triggered by Change: Execute qualification triggered by change accordingly, include protocol, and getting approved
CSV Execution: Supervise Testing and Execute Testing in CSV
Periodic Assessment: Execute periodic assessment as required
Qualification Planning and Report: Execute qualification plan and report, include protocol, and get approved
Independently finish qualification activities and solve the relative issue, give guidance to the other engineer in the team
Coordinate Qualification Implementation within technical division:
Provide the technical expertise for routine work and for Site Master Plan projects and Site Engineering projects as well. Actively cooperate with other departments, stakeholder to solve problems effectively
Prepare, review and approve specific qualification summary sections of regulatory submissions. Present the qualification program to regulatory authorities during routine and pre-approval inspections. Drive internal audit and regulatory observation responses, in addition to self identifying gaps and corrective actions for qualification deficiencies as required
Ensure timely and accurate qualification data analysis, review, reporting and trending of data in support of make, test, release and other required metrics
Recommend actions to address adverse findings and/or identify cost effective modifications to current processes as applicable
Other tasks assigned by the manager
Education/Qualifications Qualification and Experience 能力与经验
Bachelor’s Degree (Pharmaceutical / Biological is preferred) and above
Job Required Competencies 岗位所需胜任力
5 or more years qualification experience, 8 or more years MSAT/Technical or qualification experience in the injection pharmaceutical industry, MNC Bio-pharma preferred
People management experience is a plus
Prior experience in validation is advantageous
Demonstrated experience in strategic thinking, exceptional customer service skills; highly skilled in negotiations, collaboration, and influencing
Experienced in strategic project of Aseptic Filling facility including design, commissioning & qualification
Strong communications skills including the ability to communicate fluently in English, both verbally and written; holds difficult conversations and works through conflict; checks in with colleagues to ensure comprehension of key points are accurately conveyed
Strong business acumen, communications, and analytical thinking required
Strong interpersonal, leadership, collaboration and conflict resolution skills
Experienced in new facility startup readiness and operation ramp
Strong knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological industry
Experience leading major change initiatives strongly preferred
Project management skills and Leading team capability preferred
Able to think strategically and translate strategies into actionable plans, understands and applies agile ways of working
Knowledge of Quality management
Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Equal Opportunity Statement Roche is an Equal Opportunity Employer.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
#J-18808-Ljbffr