- Applies Good Manufacturing Principles in all areas of responsibility.
- Demonstrates and promotes company vision.
- Performs all activities in a safe and efficient manner.
- Oversees and manages the FCS Allentown Facilities, Utilities, Maintenance, Engineering, Validation, and Quality Risk Management, as well as the Deviation and Change Management systems. This includes ensuring timeliness, compliance, completeness and accuracy of system deliverables.
- Provides interpretation and recommends FCS Allentown's position on compliance with regulatory requirements related to Facilities, Utilities, Maintenance, Engineering, Validation, and Quality Risk Management, as well as Deviation and Change Management.
- Supports the use of TrackWise for Change and Deviation Management deliverables and will be a "power user" supporting the department and site as needed.
- Ensure internal departments maintain the highest quality standards and are aligned with all regulations/procedures by driving continuous improvement activities.
- Provides leadership in promoting and enforcing GMP and company quality requirements.
- Resolves issues potentially affecting product quality/compliance.
- Evaluates and develops techniques designed to maintain awareness of SOP's, cGMP's and clinical requirements.
- Maintains excellent client relationships by providing a technically competent QA Dept.
- Advances quality events (as necessary) to QA Director and works with QA Director to periodically review significant quality aspects of Facilities, Utilities, Maintenance, Engineering, Validation, and Quality Risk Management, as well as Deviation and Change Management.
- Quality Sponsor and interacts with clients on quality issues and is an advocate on the company's quality concept.
- Implements and monitors key performance indicators within area of responsibility.
- Provides supervision of direct reports in support of their activities.
- Provides or assists on employee training to ensure compliance with procedures and regulations.
- Provides suggestions and improvement ideas to the Quality Director related to work related processes and procedures.
- Supports and assists on regulatory and client audits.
- Assist in conducting investigations when applicable.
- Supports Quality Council and Global Quality Leadership Team initiatives.
- Other duties may be assigned to meet business needs.
- Responsible for supervising, training, reviewing, and motivating approximately 6 direct reports.
- Conducts all activities in a safe and efficient manner.
- Bachelor's degree is required.
- MS degree is preferred.
- Minimum of 5-8 years of experience in the Pharmaceutical or highly regulated industry and at least 3-5 years of direct supervisory experience required.
- Experience with Quality Systems (Change Control, deviations, complaint management, documentation management, among others), people management required.
- Experience with QA procedures in a pharmaceutical, or highly regulated environment with emphasis on documentation.
- Must have extensive familiarity with packaging paperwork and a sound understanding of cGmp's and SOP's.
- Capable of effectively managing up to 10 direct reports in a dynamic environment.
- Proficient communications skills when interacting with both internal and external parties.
- Extensive familiarity with packaging paperwork and a sound understanding of CGMP's and SOP's.
- High ethical standards required to uphold compliance.
- Thorough knowledge of Current Good Manufacturing Practices and SOP's.
- Sound knowledge of clinical packaging operations and strong leadership ability.
- Comfortable with decision-making on diversified issues and communicating directly with customers on a routine basis.
- Good organizational skills.
- Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.
- Ability to manage personnel in a cGMP environment.
- The position is administrative, is positioned in an office environment and requires standing, bending, reaching, walking, and talking as well as exerting up to 20lbs of force occasionally.
-
Section Manager
1 week ago
Cascade Industries Catasauqua, United StatesAt the Gottfried Wilhelm Leibniz University Hannover, one of the largest universities in Lower Saxony with approximately students, a position is available in the Department of Building Management for a Section Head (m/f/d) for Central Services (pay grade 11 TV-L, 100%). The Depar ...
-
Nebula Ventures Allentown, United StatesOur client is a leading provider of innovative HR software, including workforce management solutions, that helps companies efficiently manage their workforce and optimize their operations. Their solutions are tailored, intuitive, and provide real value for customers, primarily in ...
-
Velocity Solutions Dorneyville, United States"We have become the market leader in our region through a wide range of products and innovative services. Whether it's new construction, expansion, renovation, or modernization, you can find everything you need for your construction site at Dorneyville. We are part of a leading m ...
-
Spectrum Dynamics Dorneyville, United StatesWholesale and Foreign Trade Management Specialist - Wholesale Focus (m/f/d) at DorneyvilleThis is YOUR training company: Our employees are the key to our company's success - that's why we offer training every year and have a high rate of employment after completion of the trainin ...
-
Branch Manager
1 week ago
BlueHorizon Solutions Emmaus, United StatesAre you a passionate leader who takes responsibility for your team and business, and strives to delight your guests every day? Do you have a keen eye for detail while never losing sight of what truly matters - your guests and employees? Join the Emmaus family as a store manager ( ...
-
Horizon Ventures Catasauqua, United StatesTrainee - Junior Management Position for Garden Center Manager (m/f/d) · For the Berlin region · At our company, you are our top priority. And you have a whole team behind you: Because respect, mutual appreciation, and support are the most important values for us - no matter what ...
-
BIM Manager
1 week ago
NovaTech Solutions Fountain Hill, United StatesOur client is an independent, globally leading company in the field of manufacturing coating and sealing systems for structural fire protection. With decades of experience in fire protection coatings, it impresses with a consistently high quality standard and excellent processing ...
-
Branch Manager
1 week ago
Clean Harbors Lehigh Valley, United StatesHepaco, a Clean Harbors company, in Lehigh Valley, PA is seeking a Field Services Branch Manager to manage overall branch operations, including ensuring safe, cost effective, and efficient day-to-day management, as well as providing direction, growth and ensuring the success of t ...
-
Atlas Dynamics North Catasauqua, United StatesWhat to expect: · Complete internal and external project management for extensive and complex machine and plant construction projects, including commercial and technical interfaces both domestically and internationally · Ensuring cost, resource, time, and customer-oriented projec ...
-
Beverage Manager
2 weeks ago
Redner's Allentown, United StatesPOSITION TITLE: Beer and Wine Manager · DEPARTMENT:Beer and Wine · REPORTS TO: Store Director · FLSA STATUS: Non-Exempt · SUMMARY · To manage all aspects of Redner's Markets Beer and Wine operations within the supermarket. The Beer and Wine Manager will oversee all ordering, ...
-
Operations Manager
1 week ago
Gecko Hospitality Allentown, United States Full timeOperations ManagerHigh Energy New Concept to the AreaAllentown, PA$60k+ Comp Package = $ an Hour (45 hours a week) + $10k in BonusesUnlimited Growth Potential and Closed Most Holidays Strong Development, Training and Opportunities We are in search of an Operations Manager that wi ...
-
Kitchen Manager
2 weeks ago
TGIF Allentown, United StatesTGIF - 395 S Cedar Crest Blvd [Kitchen Supervisor] As a Kitchen Manager at TGIF, you'll: Manage operations during scheduled shifts that include daily decision-making, staff support, guest interaction, scheduling, planning while upholding standards, product quality and cleanliness ...
-
District Manager
5 days ago
Big Lots Stores Allentown, United States Full timeDistrict Manager Description Responsible for all activities of stores in assigned district with an emphasis on maximizing sales and profitability. Manages the execution of company initiatives and ensures compliance with company standards. Provides leadership and guidance to stor ...
-
Territory Manager
4 weeks ago
US Foods Allentown, United States Full timeJoin Our Community of Food People · The primary purpose of this position is to develop and manage established as well as new customers, by selling food and non-food items to achieve sales and profitability goals. Primary areas of responsibilities are: · • Primary owner of custom ...
-
Accounting Manager
2 weeks ago
Craft Recruiting Allentown, United StatesWe invented energy saving, solid state electrical products fifty years ago creating an industry. Today, we are at the forefront of innovating products for smart homes and connected buildings providing leadership in the human centered IoT ecosystem. With a history of innovation da ...
-
Restaurant Manager
1 week ago
Gecko Hospitality Allentown, United States Full timeRestaurant ManagerHigh Energy New Concept to the AreaAllentown, PA$50-55k Comp Package = $20-22 an Hour (40 hours a week) + $10k in BonusesUnlimited Growth Potential and Closed Most Holidays We are in search of a Restaurant Manager that will always strive to meet and exceed expe ...
-
Operations Manager
1 week ago
Gecko Hospitality Allentown, United StatesOperations Manager · High Energy New Concept to the Area · Allentown, PA · $60k+ Comp Package = $ an Hour (45 hours a week) + $10k in Bonuses · Unlimited Growth Potential and Closed Most Holidays · Strong Development, Training and Opportunities · We are in search of an Operation ...
-
Project Manager
3 days ago
Worley Allentown, United States Full timeBuilding on our past. Ready for the future · Worley is a global professional services company of energy, chemicals and resources experts. We partner with customers to deliver projects and create value over the life of their assets. We're bridging two worlds, moving towards more ...
-
Operations Manager
1 week ago
Fleet Jobs Lehigh County, United StatesAre you an energetic and team-oriented leader focused on commitment to customers, dedication to excellence and innovation? · Do you have a proven record of leadership excellence and a history of leading teams to consistently exceed established goals in dynamic operational environ ...
-
Kitchen Manager
2 weeks ago
Carrabba's Italian Grill Allentown, United StatesCarrabba's Italian Grill - 510 S Cedar Crest Blvd [Kitchen Supervisor] As a Kitchen Manager at Carrabba's Italian Grill, you'll: Be hands-on in overseeing daily restaurant operations of the HOH and instrumental in driving the business forward; Develop Micos and hold the team acco ...
Sr. Manager QA - Allentown, United States - Thermo Fisher Scientific
Description
Job DescriptionAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time - a concept that we internally adopt as "There is a Patient Waiting." Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters.
Discover Impactful Work:
The Sr Quality Manager is responsible for supporting, and at times leading, the site in implementing and promoting cGMP, regulatory and company quality requirements for our global clinical supply chain services. You will mentor and empower a large Quality team to foster a dynamic environment committed to effective and timely quality assurance activities. You will take ownership of all quality efforts - assurance, compliance, support, control - to ensure they are well coordinated and driven in collaboration with cross-functional partners.
A Day in the Life:
Education
Apply today
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.