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Senior Director, Biopharmaceutical Services job in West Chester at SGS North America

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Senior Director, Biopharmaceutical Services at SGS North America

Senior Director, Biopharmaceutical Services

SGS North America West Chester, PA Full Time
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Company Description  

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.


Job Description  

Leadership
•    Working in a leadership role with departmental, technical and scientific management, oversees all matters of personnel administration including:
o    Selection and hiring of new staff to validate they have suitable skills
o    Recommendation of employee compensation within guidelines of the corporate compensation model
o    Disposition and training/development of existing staff relating to existing & new methods or Services
o    Performance Management, disciplining and termination of department team members
o    Assignment of duties and responsibilities to all subordinate staff
•    Provides coaching, mentorship, performance management & leadership to all staff under direct control.
•    Provides support to direct staff for the management of their direct reports and will intervene to guide or provide support and/or solutions in more difficult situations
•    Sets standards and helps direct reports and their teams achieve standards for performance
•    Provide support to assist in the performance, coaching and development of staff within the site

Technical Support
•    Provide expert technical and regulatory input and support to clients, internal and other SGS groups in relation to:  Method and Process Development, Validation, Technology Transfer methods and processes
•    Make complex decisions such as establishing method validation parameters, project timelines, providing necessary resources, (people, equipment & facility) for timely completion of work
•    Responsible to help to provide assistance as needed to ensure staff investigate analytical methods and processes, for OOS/OOT, deviations and to support change control and provide input for sustainable analytical solution to processes and methodology
•    Formally investigates and approves the usage of new or unconventional problem-solving methodologies within area of expertise
•    Evaluate client requests, scope work plans and provide customer proposals for their work
•    Reviews and approves larger proposals for work involving their area
•    Provide strategic direction and input to the development and implementation of new services
•    Acts as the Principal Scientific Officer for the Laboratory and, as such, provides final approval for release by signature of all scientific reports generated by the department.
•    Establish and maintains links with other scientists from universities, regulatory agencies, and vendors, as may be required, for researching and introducing modern technologies and provides recommendations for their consideration and implementation including cost and timelines
•    Ensure timely implementation of new services once plans are approved. 
•    Assist Sales and Marketing with technical support opportunities.
•    Assist with New Business development as required
Scheduling
•    Oversee plans and schedules of activities in area to ensure on time and budget delivery are met using available resources and executed with compliance, with applicable testing protocols set by the Division, SOP’s and regulatory requirements.  
•    Through their managers and team leads, monitors the progress of active projects at all stages and provides input to their team and other departments align priorities as conflicts arise.
•    Provides recommendations and owns the implementation to expand capacity to meet future requirements
•    Liaises with other internal or external providers to develop work plans to ensure timeline and budget is met
•    May coordinate the execution of larger projects and ensure regular communication regularly with internal/external clients
•    May coordinate method transfers between clients, and internal groups  
•    Evaluate client requests, scope work plans and provide customer proposals for their work
•    Responsible to ensure resource planning to deliver client project to plan for scope, budget and time
Training
•    Provide ongoing technical training and develop staff to enable to perform technical tasks
•    Direct staff to regulatory sites to ensure current expectations are met & included in the planning & execution of work
•    Represent SGS by giving external training courses/seminars
•    Provide support to the development of others in SGS
•    When expert input is needed, help prepare and organize training on new SOP and all relevant SOP revisions and verify that training has been satisfactory.
•    Provides input to guide personal development of self & others in all matters relating to own/their roles or to guide future development and or capabilities
Quality System
•    Responsible to ensure all staff understand and operate under all applicable codes for Integrity, Regulatory and Company standards for Safety & Compliance
•    Review technical data, documents, and proposals as required and provide sign off for larger reports
•    Responsible for developing and approving departmental SOP’s.   
•    Prepare and revise appropriate quality documentation pertinent to the area of work
•    Ensure scientific, technical and compliance integrity in the design of new methods, validation and investigation of OOS and deviation events or proposals for change control
•    Works directly and leads their team to work with Quality Assurance, to support regulatory-authority and client inspections
•    Ensure that analytical data and appropriate reports/summaries contain data to satisfy regulatory requirements (e.g. Health Canada, FDA, ICH etc.).  using internal lab resources as well as external labs (e.g. SGS affiliates) as required by workload demands.
•    Provide input across all areas to help ensure our analytical practices stay current to regulatory standards and are aware of future trends
•    Ensure all staff check equipment is qualified and calibrated prior to use.
•    Ensure all staff are trained prior to execution of their work.
Labor Resources
•    Follow Corporate Human Resources (HR) requirements for the hiring of new personnel.
•    Prepare written basis for new personnel required qualifications and job description.
•    Organize and execute candidate interviews and final selection.
•    On staff dismissal, follow Corporate HR requirements and coordinate the dismissal with Business Manager and the HR Department.

Management Reporting
•    Prepare written outline on department performance with concerns and recommendations on a monthly basis.
•    Develop KPI’s with the Business Manager to help manage the area performance taking the necessary actions to achieve targets
•    Prepare written productivity report, financial highlights etc.
•    Provide information support regarding Budgets & Forecasts to Business Manager as required. 
•    May, in the absence of the Business Manager, act as the most senior manager in residence and perform the duties of the Manager.
•    Perform other duties as assigned by the Business Manager


Qualifications  

“In the course of employment, you will be required to travel to and/or work at a client site.  The company requires employees to be vaccinated against COVID-19 in order to travel commercially and many clients require visitors performing work at their locations to be vaccinated.  Therefore, this role requires a candidate who is fully vaccinated or will be prior to an anticipated start date.  The successful candidate will be required to provide proof of having received a COVID-19 vaccination.

 The company will provide a reasonable accommodation upon request after an offer is extended.”

EDUCATION AND EXPERIENCE 

Required: 
•    Postgraduate degree in Biochemistry, Chemistry or a related science degree with Holding a PhD would be a strong asset.
•    Minimum 10 years post graduate experience with strong management experience in a regulated analytical laboratory with a heavy focus on Research, Method Development and Design and Validation.
                                                                                                                                      KNOWLEDGE / SKILLS / ABILITIES
•    Language Skills: English/French/Spanish/Other describe if Other Basic/Intermediate/Advanced/ Highest level of knowledge required/preferred
•    Mathematical Skills: Basic/Intermediate/Advanced/Highest level of knowledge required/preferred
•    Reasoning Skills/Abilities: Basic/Intermediate/Advanced level required/preferred
•    Computer Skills: Provide details, designate a level of expertise required/preferred.
•    List other knowledge/skills or abilities required/preferred for performing the job.

TRAVEL 
•    Travel is minor by car, plane, and/or train, to client sites or other SGS locations. 

EQUIPMENT
•    This job operates in a professional office environment. This role routinely uses standard office equipment such as computers and phones. 

PHYSICAL DEMANDS OF THE JOB
Physical/Sensory Demands Frequency Requirements:
•    Stand – Occasionally 
•    Move or traverse – Occasionally
•    Sit - Constantly
•    Use hands - Frequently
•    Reach with hands and arms - Occasionally
•    Climb or balance - None
•    Stoop, kneel, crouch or crawl - None
 


Additional Information  

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

o perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call

201-508-3149
for assistance and leave a message. You will receive a call back.  Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability

All your information will be kept confidential according to EEO guidelines.

 

Recommended Skills

  • Administration
  • Biochemistry
  • Business Development
  • English
  • Finance
  • Financial Management
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